Document GzmQXZpvk4QxNOkb2g8jD1ER7

Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 1 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ Appendix E: Histopathological Findings Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 2 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ Table 1: Summary of histopathological findings (all animals) FRAUNHOFER ITA 01G0002 Summary of histopathological findings (all animals) Page: 1 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 1 ! 2 ! 1 ! 4 ! 2 ! 2 ! 3 ! 3 ! ! !(25%)!(13%)!(25%)!(13%)!(50%)!(25%)!(25%)!(38%)!(38%)! ! Epidermal hypertrophy/hyperplasia ! 6 ! 7 ! 6 ! 7 ! 4 ! 6 ! 6 ! 5 ! 5 ! ! !(75%)!(88%)!(75%)!(88%)!(50%)!(75%)!(75%)!(63%)!(63%)! ! Hyperkeratosis ! 0 ! 1 ! 1 ! 1 ! 1 ! 1 ! 0 ! 0 ! 2 ! ! !(0%) !(13%)!(13%)!(13%)!(13%)!(13%)!(0%) !(0%) !(25%)! ! Ulcerative inflammation ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Epidermal erosion(s) ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) ! ! Dermal inflammatory cell infiltration ! 0 ! 3 ! 1 ! 2 ! 1 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(38%)!(13%)!(25%)!(13%)!(13%)!(0%) !(0%) !(13%)! ! Subcutaneous inflammatory cell infiltration ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 8 ! 8 ! 7 ! 8 ! 8 ! 8 ! 7 ! 8 ! 8 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 8 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 8 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! (Ulcerative) inflammation ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(13%)!(0%) !(0%) ! ! Epidermal hyperplasia ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(13%)!(0%) !(0%) ! ! Hyperkeratosis ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Dermal fibrosis ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 7 ! 7 ! 6 ! 7 ! 7 ! 8 ! 6 ! 8 ! 6 ! ! ! ( 8 8 % ) ! ( 8 8 % ) ! ( 7 5 % ) ! ( 8 8 % ) ! ( 8 8 % ) !( 1 0 0 % ) ! ( 7 5 % ) !( 1 0 0 % ) ! ( 7 5 % ) ! ! Myocardial degeneration ! 1 ! 1 ! 1 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! ! !(13%)!(13%)!(13%)!(0%) !(13%)!(0%) !(13%)!(0%) !(0%) ! ! Myocardial mononuclear cell infiltration ! 1 ! 1 ! 2 ! 1 ! 1 ! 0 ! 2 ! 0 ! 2 ! ! !(13%)!(13%)!(25%)!(13%)!(13%)!(0%) !(25%)!(0%) !(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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 3 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Summary of histopathological findings (all animals) Page: 2 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 6 ! 7 ! 7 ! 7 ! 6 ! 8 ! 7 ! 6 ! 8 ! ! ! ( 7 5 % ) ! ( 8 8 % ) ! ( 8 8 % ) ! ( 8 8 % ) ! ( 7 5 % ) !( 1 0 0 % ) ! ( 8 8 % ) ! ( 7 5 % ) !( 1 0 0 % ) ! ! Hepatodiaphragmatic nodule ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) ! ! Hepatocellular necrosis ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Granulation tissue ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Mononuclear cell infiltration ! 2 ! 0 ! 1 ! 0 ! 2 ! 0 ! 0 ! 2 ! 0 ! ! !(25%)!(0%) !(13%)!(0%) !(25%)!(0%) !(0%) !(25%)!(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 6 ! 8 ! 4 ! 7 ! 4 ! 7 ! 6 ! 5 ! 6 ! ! ! ( 7 5 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 8 8 % ) ! ( 5 0 % ) ! ( 8 8 % ) ! ( 7 5 % ) ! ( 6 3 % ) ! ( 7 5 % ) ! ! Cortical scar(s) ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! T u b u l a r -c e l l d e g e n e r a t i o n ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Tubular basophilia ! 2 ! 0 ! 1 ! 1 ! 4 ! 0 ! 0 ! 1 ! 1 ! ! !(25%)!(0%) !(13%)!(13%)!(50%)!(0%) !(0%) !(13%)!(13%)! ! Tubular dilatation with luminal hyaline substances ! 0 ! 0 ! 1 ! 0 ! 1 ! 1 ! 2 ! 2 ! 1 ! ! !(0%) !(0%) !(13%)!(0%) !(13%)!(13%)!(25%)!(25%)!(13%)! ! Interstitial mononuclear cell infiltration ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) ! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 7 ! 7 ! 5 ! 6 ! 7 ! 8 ! 8 ! 8 ! 7 ! ! ! ( 8 8 % ) ! ( 8 8 % ) ! ( 6 3 % ) ! ( 7 5 % ) ! ( 8 8 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 8 % ) ! ! Cortical fatty cytoplasmic vacuolation ! 1 ! 1 ! 3 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(13%)!(13%)!(38%)!(0%) !(13%)!(0%) !(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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 4 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Summary of histopathological findings (all animals) Page: 3 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! Accessory cortical nodule (rest) ! 0 ! 0 ! 0 ! 2 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(25%)!(0%) !(0%) !(0%) !(0%) !(13%)! ! ! ! ! ! ! ! ! ! ! ! !TESTES ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !CEREBRUM ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !THYMUS ! ! ! ! ! ! ! ! (1) ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! Haemorrhage ! ! ! ! ! ! ! ! 1 ! 1 ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 5 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Summary of histopathological findings (all animals) Page: 4 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 0 ! 0 ! 2 ! 1 ! 1 ! 0 ! 0 ! 1 ! 2 ! ! !(0%) !(0%) !(25%)!(13%)!(13%)!(0%) !(0%) !(13%)!(25%)! ! Epidermal hypertrophy/hyperplasia ! 8 ! 8 ! 6 ! 7 ! 7 ! 8 ! 8 ! 7 ! 6 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 7 5 % ) ! ( 8 8 % ) ! ( 8 8 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 8 % ) ! ( 7 5 % ) ! ! Hyperkeratosis ! 2 ! 1 ! 2 ! 2 ! 1 ! 3 ! 1 ! 2 ! 1 ! ! !(25%)!(13%)!(25%)!(25%)!(13%)!(38%)!(13%)!(25%)!(13%)! ! Epidermal erosion(s) ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) ! ! Dermal inflammatory cell infiltration ! 2 ! 1 ! 1 ! 2 ! 1 ! 2 ! 0 ! 2 ! 0 ! ! !(25%)!(13%)!(13%)!(25%)!(13%)!(25%)!(0%) !(25%)!(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 6 ! 8 ! 7 ! 6 ! 8 ! 6 ! 8 ! 7 ! 5 ! ! ! ( 7 5 % ) !( 1 0 0 % ) ! ( 8 8 % ) ! ( 7 5 % ) !( 1 0 0 % ) ! ( 7 5 % ) !( 1 0 0 % ) ! ( 8 8 % ) ! ( 6 3 % ) ! ! (Ulcerative) inflammation ! 1 ! 0 ! 1 ! 2 ! 0 ! 1 ! 0 ! 0 ! 3 ! ! !(13%)!(0%) !(13%)!(25%)!(0%) !(13%)!(0%) !(0%) !(38%)! ! Epidermal erosion(s) ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Dermal inflammatory cell infiltration ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Subcutaneous inflammatory cell infiltration ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(13%)!(0%) ! ! Epidermal hyperplasia ! 2 ! 0 ! 1 ! 2 ! 0 ! 1 ! 0 ! 0 ! 3 ! ! !(25%)!(0%) !(13%)!(25%)!(0%) !(13%)!(0%) !(0%) !(38%)! ! Hyperkeratosis ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 3 ! ! !(0%) !(0%) !(0%) !(13%)!(0%) !(13%)!(0%) !(0%) !(38%)! ! Haemorrhage ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 7 ! 8 ! 8 ! 7 ! 8 ! 8 ! 7 ! 8 ! 8 ! ! ! ( 8 8 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 8 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 8 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Myocardial mononuclear cell infiltration ! 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 6 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Summary of histopathological findings (all animals) Page: 5 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 8 ! 8 ! 7 ! 8 ! 7 ! 8 ! 4* ! 7 ! 7 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 8 % ) !( 1 0 0 % ) ! ( 8 8 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 8 8 % ) ! ( 8 8 % ) ! ! Hepatodiaphragmatic nodule ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(13%)! ! Mononuclear cell infiltration ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 3 ! 1 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(13%)!(0%) !(38%)!(13%)!(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 7 ! 8 ! 7 ! 6 ! 5 ! 7 ! 6 ! 8 ! 4 ! ! ! ( 8 8 % ) !( 1 0 0 % ) ! ( 8 8 % ) ! ( 7 5 % ) ! ( 6 3 % ) ! ( 8 8 % ) ! ( 7 5 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! Cortical scar(s) ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) ! ! T u b u l a r -c e l l d e g e n e r a t i o n ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Tubular mineralisation ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Tubular basophilia ! 0 ! 0 ! 1 ! 0 ! 2 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(13%)!(0%) !(25%)!(13%)!(0%) !(0%) !(13%)! ! Tubular dilatation with luminal hyaline substances ! 0 ! 0 ! 0 ! 1 ! 1 ! 0 ! 0 ! 0 ! 3 ! ! !(0%) !(0%) !(0%) !(13%)!(13%)!(0%) !(0%) !(0%) !(38%)! ! Interstitial mononuclear cell infiltration ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(13%)! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 7 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 8 % ) ! ! Accessory cortical nodule (rest) ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 7 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Summary of histopathological findings (all animals) Page: 6 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !OVARIES ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 7 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 8 % ) ! ! Cyst(s) ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)! ! ! ! ! ! ! ! ! ! ! ! !PITUITARY ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! Cyst(s) ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !THYMUS ! ! ! ! ! ! ! ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! ! ! ! ! ! ! ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !UTERUS ! ! ! ! ! ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! Dilatation ! ! ! ! ! ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! ! ! !ABDOMINAL CAVITY ! ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! Fat necrosis ! ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 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 *** Listing Complete *** Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 8 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ Table 2: Summary of histopathological findings (with scores, all animals) FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, all animals) Page: 1 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 1 ! 2 ! 1 ! 4 ! 2 ! 2 ! 3 ! 3 ! ! !(25%)!(13%)!(25%)!(13%)!(50%)!(25%)!(25%)!(38%)!(38%)! ! Epidermal hypertrophy/hyperplasia ! ! ! ! ! ! ! ! ! ! ! very slight ! 6 ! 6 ! 5 ! 4 ! 4 ! 5 ! 5 ! 5 ! 3 ! ! !(75%)!(75%)!(63%)!(50%)!(50%)!(63%)!(63%)!(63%)!(38%)! ! slight ! 0 ! 1 ! 1 ! 3 ! 0 ! 1 ! 1 ! 0 ! 2 ! ! !(0%) !(13%)!(13%)!(38%)!(0%) !(13%)!(13%)!(0%) !(25%)! ! Score Expanded Totals ! 6 ! 7 ! 6 ! 7 ! 4 ! 6 ! 6 ! 5 ! 5 ! ! !(75%)!(88%)!(75%)!(88%)!(50%)!(75%)!(75%)!(63%)!(63%)! ! Hyperkeratosis ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 1 ! 1 ! 1 ! 1 ! 1 ! 0 ! 0 ! 2 ! ! !(0%) !(13%)!(13%)!(13%)!(13%)!(13%)!(0%) !(0%) !(25%)! ! Score Expanded Totals ! 0 ! 1 ! 1 ! 1 ! 1 ! 1 ! 0 ! 0 ! 2 ! ! !(0%) !(13%)!(13%)!(13%)!(13%)!(13%)!(0%) !(0%) !(25%)! ! Ulcerative inflammation ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Epidermal erosion(s) ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) ! ! Dermal inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! very slight ! 0 ! 2 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(25%)!(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! slight ! 0 ! 1 ! 0 ! 2 ! 1 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(13%)!(0%) !(25%)!(13%)!(13%)!(0%) !(0%) !(13%)! ! Score Expanded Totals ! 0 ! 3 ! 1 ! 2 ! 1 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(38%)!(13%)!(25%)!(13%)!(13%)!(0%) !(0%) !(13%)! ! Subcutaneous inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) ! ! Score Expanded Totals ! 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 9 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, all animals) Page: 2 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 8 ! 8 ! 7 ! 8 ! 8 ! 8 ! 7 ! 8 ! 8 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 8 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 8 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! (Ulcerative) inflammation ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) ! ! moderate ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(13%)!(0%) !(0%) ! ! Epidermal hyperplasia ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) ! ! severe ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(13%)!(0%) !(0%) ! ! Hyperkeratosis ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Dermal fibrosis ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 7 ! 7 ! 6 ! 7 ! 7 ! 8 ! 6 ! 8 ! 6 ! ! ! ( 8 8 % ) ! ( 8 8 % ) ! ( 7 5 % ) ! ( 8 8 % ) ! ( 8 8 % ) !( 1 0 0 % ) ! ( 7 5 % ) !( 1 0 0 % ) ! ( 7 5 % ) ! ! Myocardial degeneration ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 1 ! 1 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! ! !(13%)!(13%)!(13%)!(0%) !(13%)!(0%) !(13%)!(0%) !(0%) ! ! Score Expanded Totals ! 1 ! 1 ! 1 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! ! !(13%)!(13%)!(13%)!(0%) !(13%)!(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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 10 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, all animals) Page: 3 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! Myocardial mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! very slight ! 0 ! 0 ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(13%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! slight ! 1 ! 1 ! 1 ! 0 ! 1 ! 0 ! 2 ! 0 ! 2 ! ! !(13%)!(13%)!(13%)!(0%) !(13%)!(0%) !(25%)!(0%) !(25%)! ! Score Expanded Totals ! 1 ! 1 ! 2 ! 1 ! 1 ! 0 ! 2 ! 0 ! 2 ! ! !(13%)!(13%)!(25%)!(13%)!(13%)!(0%) !(25%)!(0%) !(25%)! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 6 ! 7 ! 7 ! 7 ! 6 ! 8 ! 7 ! 6 ! 8 ! ! ! ( 7 5 % ) ! ( 8 8 % ) ! ( 8 8 % ) ! ( 8 8 % ) ! ( 7 5 % ) !( 1 0 0 % ) ! ( 8 8 % ) ! ( 7 5 % ) !( 1 0 0 % ) ! ! Hepatodiaphragmatic nodule ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) ! ! Hepatocellular necrosis ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Granulation tissue ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 2 ! 0 ! 1 ! 0 ! 2 ! 0 ! 0 ! 2 ! 0 ! ! !(25%)!(0%) !(13%)!(0%) !(25%)!(0%) !(0%) !(25%)!(0%) ! ! Score Expanded Totals ! 2 ! 0 ! 1 ! 0 ! 2 ! 0 ! 0 ! 2 ! 0 ! ! !(25%)!(0%) !(13%)!(0%) !(25%)!(0%) !(0%) !(25%)!(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 11 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, all animals) Page: 4 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 6 ! 8 ! 4 ! 7 ! 4 ! 7 ! 6 ! 5 ! 6 ! ! ! ( 7 5 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 8 8 % ) ! ( 5 0 % ) ! ( 8 8 % ) ! ( 7 5 % ) ! ( 6 3 % ) ! ( 7 5 % ) ! ! Cortical scar(s) ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! T u b u l a r -c e l l d e g e n e r a t i o n ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Tubular basophilia ! ! ! ! ! ! ! ! ! ! ! very slight ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! slight ! 1 ! 0 ! 1 ! 1 ! 4 ! 0 ! 0 ! 1 ! 1 ! ! !(13%)!(0%) !(13%)!(13%)!(50%)!(0%) !(0%) !(13%)!(13%)! ! Score Expanded Totals ! 2 ! 0 ! 1 ! 1 ! 4 ! 0 ! 0 ! 1 ! 1 ! ! !(25%)!(0%) !(13%)!(13%)!(50%)!(0%) !(0%) !(13%)!(13%)! ! Tubular dilatation with luminal hyaline substances ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 1 ! 0 ! 1 ! 1 ! 2 ! 2 ! 1 ! ! !(0%) !(0%) !(13%)!(0%) !(13%)!(13%)!(25%)!(25%)!(13%)! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 1 ! 1 ! 2 ! 2 ! 1 ! ! !(0%) !(0%) !(13%)!(0%) !(13%)!(13%)!(25%)!(25%)!(13%)! ! Interstitial mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) ! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 7 ! 7 ! 5 ! 6 ! 7 ! 8 ! 8 ! 8 ! 7 ! ! ! ( 8 8 % ) ! ( 8 8 % ) ! ( 6 3 % ) ! ( 7 5 % ) ! ( 8 8 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 8 % ) ! ! Cortical fatty cytoplasmic vacuolation ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 1 ! 3 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(13%)!(13%)!(38%)!(0%) !(13%)!(0%) !(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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 12 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, all animals) Page: 5 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! Cortical fatty cytoplasmic vacuolation ! ! ! ! ! ! ! ! ! ! ! Score Expanded Totals ! 1 ! 1 ! 3 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(13%)!(13%)!(38%)!(0%) !(13%)!(0%) !(0%) !(0%) !(0%) ! ! Accessory cortical nodule (rest) ! 0 ! 0 ! 0 ! 2 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(25%)!(0%) !(0%) !(0%) !(0%) !(13%)! ! ! ! ! ! ! ! ! ! ! ! !TESTES ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !CEREBRUM ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !THYMUS ! ! ! ! ! ! ! ! (1) ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! Haemorrhage ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! ! ! ! 1 ! 1 ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ! Score Expanded Totals ! ! ! ! ! ! ! ! 1 ! 1 ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 13 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, all animals) Page: 6 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 0 ! 0 ! 2 ! 1 ! 1 ! 0 ! 0 ! 1 ! 2 ! ! !(0%) !(0%) !(25%)!(13%)!(13%)!(0%) !(0%) !(13%)!(25%)! ! Epidermal hypertrophy/hyperplasia ! ! ! ! ! ! ! ! ! ! ! very slight ! 4 ! 6 ! 4 ! 6 ! 6 ! 5 ! 7 ! 5 ! 5 ! ! !(50%)!(75%)!(50%)!(75%)!(75%)!(63%)!(88%)!(63%)!(63%)! ! slight ! 4 ! 2 ! 2 ! 1 ! 1 ! 3 ! 1 ! 2 ! 1 ! ! !(50%)!(25%)!(25%)!(13%)!(13%)!(38%)!(13%)!(25%)!(13%)! ! Score Expanded Totals ! 8 ! 8 ! 6 ! 7 ! 7 ! 8 ! 8 ! 7 ! 6 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 7 5 % ) ! ( 8 8 % ) ! ( 8 8 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 8 % ) ! ( 7 5 % ) ! ! Hyperkeratosis ! ! ! ! ! ! ! ! ! ! ! slight ! 2 ! 1 ! 2 ! 2 ! 1 ! 3 ! 1 ! 2 ! 1 ! ! !(25%)!(13%)!(25%)!(25%)!(13%)!(38%)!(13%)!(25%)!(13%)! ! Score Expanded Totals ! 2 ! 1 ! 2 ! 2 ! 1 ! 3 ! 1 ! 2 ! 1 ! ! !(25%)!(13%)!(25%)!(25%)!(13%)!(38%)!(13%)!(25%)!(13%)! ! Epidermal erosion(s) ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) ! ! Dermal inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! very slight ! 2 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(25%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! slight ! 0 ! 1 ! 1 ! 2 ! 1 ! 2 ! 0 ! 2 ! 0 ! ! !(0%) !(13%)!(13%)!(25%)!(13%)!(25%)!(0%) !(25%)!(0%) ! ! Score Expanded Totals ! 2 ! 1 ! 1 ! 2 ! 1 ! 2 ! 0 ! 2 ! 0 ! ! !(25%)!(13%)!(13%)!(25%)!(13%)!(25%)!(0%) !(25%)!(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 6 ! 8 ! 7 ! 6 ! 8 ! 6 ! 8 ! 7 ! 5 ! ! ! ( 7 5 % ) !( 1 0 0 % ) ! ( 8 8 % ) ! ( 7 5 % ) !( 1 0 0 % ) ! ( 7 5 % ) !( 1 0 0 % ) ! ( 8 8 % ) ! ( 6 3 % ) ! ! (Ulcerative) inflammation ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(13%)! ! moderate ! 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 14 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, all animals) Page: 7 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! (Ulcerative) inflammation ! ! ! ! ! ! ! ! ! ! ! severe ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)! ! Score Expanded Totals ! 1 ! 0 ! 1 ! 2 ! 0 ! 1 ! 0 ! 0 ! 3 ! ! !(13%)!(0%) !(13%)!(25%)!(0%) !(13%)!(0%) !(0%) !(38%)! ! Epidermal erosion(s) ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Dermal inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Subcutaneous inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) ! ! moderate ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(13%)!(0%) ! ! Epidermal hyperplasia ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(13%)! ! moderate ! 2 ! 0 ! 1 ! 2 ! 0 ! 0 ! 0 ! 0 ! 2 ! ! !(25%)!(0%) !(13%)!(25%)!(0%) !(0%) !(0%) !(0%) !(25%)! ! Score Expanded Totals ! 2 ! 0 ! 1 ! 2 ! 0 ! 1 ! 0 ! 0 ! 3 ! ! !(25%)!(0%) !(13%)!(25%)!(0%) !(13%)!(0%) !(0%) !(38%)! ! Hyperkeratosis ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(13%)! ! moderate ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 2 ! ! !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(25%)! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 3 ! ! !(0%) !(0%) !(0%) !(13%)!(0%) !(13%)!(0%) !(0%) !(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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 15 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, all animals) Page: 8 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! Haemorrhage ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 7 ! 8 ! 8 ! 7 ! 8 ! 8 ! 7 ! 8 ! 8 ! ! ! ( 8 8 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 8 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 8 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Myocardial mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(13%)!(0%) !(0%) !(13%)!(0%) !(0%) !(13%)!(0%) !(0%) ! ! Score Expanded Totals ! 1 ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(13%)!(0%) !(0%) !(13%)!(0%) !(0%) !(13%)!(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 8 ! 8 ! 7 ! 8 ! 7 ! 8 ! 4* ! 7 ! 7 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 8 % ) !( 1 0 0 % ) ! ( 8 8 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 8 8 % ) ! ( 8 8 % ) ! ! Hepatodiaphragmatic nodule ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(13%)! ! Mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 3 ! 1 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(13%)!(0%) !(38%)!(13%)!(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 3 ! 1 ! 0 ! ! !(0%) !(0%) !(13%)!(0%) !(13%)!(0%) !(38%)!(13%)!(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 7 ! 8 ! 7 ! 6 ! 5 ! 7 ! 6 ! 8 ! 4 ! ! ! ( 8 8 % ) !( 1 0 0 % ) ! ( 8 8 % ) ! ( 7 5 % ) ! ( 6 3 % ) ! ( 8 8 % ) ! ( 7 5 % ) !( 1 0 0 % ) ! ( 5 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 16 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, all animals) Page: 9 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! Cortical scar(s) ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) ! ! T u b u l a r -c e l l d e g e n e r a t i o n ! ! ! ! ! ! ! ! ! ! ! very slight ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Tubular mineralisation ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Tubular basophilia ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 1 ! 0 ! 2 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(13%)!(0%) !(25%)!(13%)!(0%) !(0%) !(13%)! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 2 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(13%)!(0%) !(25%)!(13%)!(0%) !(0%) !(13%)! ! Tubular dilatation with luminal hyaline substances ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 1 ! 1 ! 0 ! 0 ! 0 ! 3 ! ! !(0%) !(0%) !(0%) !(13%)!(13%)!(0%) !(0%) !(0%) !(38%)! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 1 ! 1 ! 0 ! 0 ! 0 ! 3 ! ! !(0%) !(0%) !(0%) !(13%)!(13%)!(0%) !(0%) !(0%) !(38%)! ! Interstitial mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)! ! moderate ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)!(0%) !(13%)! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 7 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 17 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Summary of histopathological findings (with scores, all animals) Page: 10 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! Accessory cortical nodule (rest) ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)! ! ! ! ! ! ! ! ! ! ! ! !OVARIES ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 8 ! 7 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 8 8 % ) ! ! Cyst(s) ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(13%)! ! ! ! ! ! ! ! ! ! ! ! !PITUITARY ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! Cyst(s) ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !THYMUS ! ! ! ! ! ! ! ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! ! ! ! ! ! ! ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !UTERUS ! ! ! ! ! ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! Dilatation ! ! ! ! ! ! ! ! ! ! ! moderate ! ! ! ! ! ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) ! ! ! ! Score Expanded Totals ! ! ! ! ! ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! ! ! !ABDOMINAL CAVITY ! ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! Fat necrosis ! ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 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 *** Listing Complete *** Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 18 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ Table 3: Summary of histopathological findings (4-days treatment) FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( 4 -d a y s t r e a t m e n t ) Page: 1 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(50%)!(0%) ! ! Epidermal hypertrophy/hyperplasia ! 2 ! 2 ! 1 ! 2 ! 1 ! 2 ! 2 ! 1 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ! Hyperkeratosis ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(50%)! ! Epidermal erosion(s) ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) ! ! Dermal inflammatory cell infiltration ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(50%)! ! Subcutaneous inflammatory cell infiltration ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 2 ! 1 ! 2 ! 1 ! 1 ! 2 ! 2 ! 2 ! ! ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 19 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( 4 -d a y s t r e a t m e n t ) Page: 2 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! Cortical scar(s) ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Tubular basophilia ! 1 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) ! ! Tubular dilatation with luminal hyaline substances ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 2 ! 1 ! 1 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Cortical fatty cytoplasmic vacuolation ! 1 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Accessory cortical nodule (rest) ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !TESTES ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !THYMUS ! ! ! ! ! ! ! ! (1) ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! Haemorrhage ! ! ! ! ! ! ! ! 1 ! 1 ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 20 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( 4 -d a y s t r e a t m e n t ) Page: 3 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Epidermal hypertrophy/hyperplasia ! 2 ! 2 ! 1 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Hyperkeratosis ! 1 ! 0 ! 0 ! 0 ! 1 ! 1 ! 1 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(50%)!(50%)!(50%)!(0%) !(0%) ! ! Dermal inflammatory cell infiltration ! 2 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !( 1 0 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! 1 ! 1 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ! Hepatodiaphragmatic nodule ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)! ! Mononuclear cell infiltration ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(50%)!(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 2 ! 2 ! 1 ! 2 ! 2 ! 1 ! 2 ! 1 ! ! ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 21 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( 4 -d a y s t r e a t m e n t ) Page: 4 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! Cortical scar(s) ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! T u b u l a r -c e l l d e g e n e r a t i o n ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Tubular mineralisation ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Tubular dilatation with luminal hyaline substances ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !OVARIES ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !THYMUS ! ! ! ! ! ! ! ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! ! ! ! ! ! ! ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !UTERUS ! ! ! ! ! ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! Dilatation ! ! ! ! ! ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 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 *** Listing Complete *** Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 22 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ Table 4: Summary of histopathological findings (with scores, 4-days treatment) FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 4 -d a y s t r e a t m e n t ) Page: 1 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(50%)!(0%) ! ! Epidermal hypertrophy/hyperplasia ! ! ! ! ! ! ! ! ! ! ! very slight ! 2 ! 2 ! 1 ! 1 ! 1 ! 2 ! 1 ! 1 ! 1 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ! slight ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(50%)!(0%) !(50%)! ! Score Expanded Totals ! 2 ! 2 ! 1 ! 2 ! 1 ! 2 ! 2 ! 1 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ! Hyperkeratosis ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(50%)! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(50%)! ! Epidermal erosion(s) ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) ! ! Dermal inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(50%)! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(50%)! ! Subcutaneous inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 23 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ F R AU N H O F E R I T A 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 4 -d a y s t r e a t m e n t ) Page: 2 2 1 -Au g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E AT M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! ! H E AR T ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 2 ! 1 ! 2 ! 1 ! 1 ! 2 ! 2 ! 2 ! ! ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Cortical scar(s) ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Tubular basophilia ! ! ! ! ! ! ! ! ! ! ! very slight ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! slight ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 1 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) ! ! Tubular dilatation with luminal hyaline substances ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 24 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 4 -d a y s t r e a t m e n t ) Page: 3 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 2 ! 1 ! 1 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Cortical fatty cytoplasmic vacuolation ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 1 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Accessory cortical nodule (rest) ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !TESTES ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !THYMUS ! ! ! ! ! ! ! ! (1) ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! Haemorrhage ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! ! ! ! 1 ! 1 ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ! Score Expanded Totals ! ! ! ! ! ! ! ! 1 ! 1 ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 25 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 4 -d a y s t r e a t m e n t ) Page: 4 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Epidermal hypertrophy/hyperplasia ! ! ! ! ! ! ! ! ! ! ! very slight ! 0 ! 2 ! 1 ! 2 ! 2 ! 1 ! 2 ! 2 ! 2 ! ! ! ( 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! slight ! 2 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! ! !( 1 0 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ! Score Expanded Totals ! 2 ! 2 ! 1 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Hyperkeratosis ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 0 ! 0 ! 0 ! 1 ! 1 ! 1 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(50%)!(50%)!(50%)!(0%) !(0%) ! ! Score Expanded Totals ! 1 ! 0 ! 0 ! 0 ! 1 ! 1 ! 1 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(50%)!(50%)!(50%)!(0%) !(0%) ! ! Dermal inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! very slight ! 2 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !( 1 0 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ! Score Expanded Totals ! 2 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !( 1 0 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! 1 ! 1 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ! Hepatodiaphragmatic nodule ! 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 26 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 4 -d a y s t r e a t m e n t ) Page: 5 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! Mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(50%)!(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(50%)!(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 2 ! 2 ! 1 ! 2 ! 2 ! 1 ! 2 ! 1 ! ! ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! Cortical scar(s) ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! T u b u l a r -c e l l d e g e n e r a t i o n ! ! ! ! ! ! ! ! ! ! ! very slight ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Tubular mineralisation ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Tubular dilatation with luminal hyaline substances ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)! ! Score Expanded Totals ! 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 27 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 4 -d a y s t r e a t m e n t ) Page: 6 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !OVARIES ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !THYMUS ! ! ! ! ! ! ! ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! ! ! ! ! ! ! ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !UTERUS ! ! ! ! ! ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! Dilatation ! ! ! ! ! ! ! ! ! ! ! moderate ! ! ! ! ! ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) ! ! ! ! Score Expanded Totals ! ! ! ! ! ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 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 *** Listing Complete *** Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 28 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ Table 5: Summary of histopathological findings (14-days treatment) F R A U N H O F E R I TA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( 1 4 -d a y s t r e a t m e n t ) Page: 1 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! I N C I D E N C E O F L E S I O N S ( P E R C E N T) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! TR E A TM E N T !s a l i n e !T- !T- !T- !T- !T- !T- !T- !T- ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! ! S K I N ( TR E A TE D S I TE ) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)! ! Epidermal hypertrophy/hyperplasia ! 1 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! ! ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! Hyperkeratosis ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(50%)!(0%) !(0%) !(0%) ! ! Dermal inflammatory cell infiltration ! 0 ! 2 ! 1 ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! ! ( 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! ! S K I N ( U N TR E A TE D S I TE ) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Ulcerative inflammation ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! Epidermal hyperplasia ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 1 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! Myocardial mononuclear cell infiltration ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(50%)! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 2 ! 1 ! 2 ! 1 ! 2 ! 2 ! 1 ! 2 ! ! ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ! Mononuclear cell infiltration ! 1 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 1 ! 0 ! ! !(50%)!(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(50%)!(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 29 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( 1 4 -d a y s t r e a t m e n t ) Page: 2 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 1 ! 2 ! 1 ! 2 ! 2 ! 0 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ! T u b u l a r -c e l l d e g e n e r a t i o n ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Tubular basophilia ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) ! ! Tubular dilatation with luminal hyaline substances ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) ! ! Interstitial mononuclear cell infiltration ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) ! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 1 ! 1 ! 1 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Cortical fatty cytoplasmic vacuolation ! 0 ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(50%)!(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Accessory cortical nodule (rest) ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !TESTES ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 30 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( 1 4 -d a y s t r e a t m e n t ) Page: 3 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! Epidermal hypertrophy/hyperplasia ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Hyperkeratosis ! 1 ! 1 ! 2 ! 1 ! 0 ! 2 ! 0 ! 0 ! 1 ! ! ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ! Dermal inflammatory cell infiltration ! 0 ! 0 ! 1 ! 1 ! 0 ! 2 ! 0 ! 0 ! 0 ! ! ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 1 ! 2 ! 1 ! 2 ! 1 ! 1 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ! Ulcerative inflammation ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(50%)! ! Subcutaneous inflammatory cell infiltration ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) ! ! Epidermal hyperplasia ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(50%)! ! Hyperkeratosis ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(50%)! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 2 ! 2 ! 1 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Myocardial mononuclear cell infiltration ! 1 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Hepatodiaphragmatic nodule ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 31 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( 1 4 -d a y s t r e a t m e n t ) Page: 4 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! 2 ! 1 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! Interstitial mononuclear cell infiltration ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(50%)! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !OVARIES ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 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 *** Listing Complete *** Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 32 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ Table 6: Summary of histopathological findings (with scores, 14-days treatment) F R A U N H O F E R I TA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 1 4 -d a y s t r e a t m e n t ) Page: 1 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! I N C I D E N C E O F L E S I O N S ( P E R C E N T) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! TR E A TM E N T !s a l i n e !T- !T- !T- !T- !T- !T- !T- !T- ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! ! S K I N ( TR E A TE D S I TE ) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)! ! Epidermal hypertrophy/hyperplasia ! ! ! ! ! ! ! ! ! ! ! very slight ! 1 ! 2 ! 1 ! 2 ! 2 ! 1 ! 2 ! 2 ! 1 ! ! ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! slight ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(50%)!(0%) !(0%) !(0%) ! ! S c o r e E x p a n d e d To t a l s ! 1 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! ! ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! Hyperkeratosis ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(50%)!(0%) !(0%) !(0%) ! ! S c o r e E x p a n d e d To t a l s ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(50%)!(0%) !(0%) !(0%) ! ! Dermal inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! very slight ! 0 ! 2 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! ! ( 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ! slight ! 0 ! 0 ! 0 ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(50%)!(0%) !(0%) !(0%) !(0%) ! ! S c o r e E x p a n d e d To t a l s ! 0 ! 2 ! 1 ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! ! ( 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! ! S K I N ( U N TR E A TE D S I TE ) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Ulcerative inflammation ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! S c o r e E x p a n d e d To t a l s ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! Epidermal hyperplasia ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! S c o r e E x p a n d e d To t a l s ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 33 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 1 4 -d a y s t r e a t m e n t ) Page: 2 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 1 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! Myocardial mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! very slight ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(50%)! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 2 ! 1 ! 2 ! 1 ! 2 ! 2 ! 1 ! 2 ! ! ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ! Mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 1 ! 0 ! ! !(50%)!(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(50%)!(0%) ! ! Score Expanded Totals ! 1 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 1 ! 0 ! ! !(50%)!(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(50%)!(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 1 ! 2 ! 1 ! 2 ! 2 ! 0 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ! T u b u l a r -c e l l d e g e n e r a t i o n ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Tubular basophilia ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 34 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 1 4 -d a y s t r e a t m e n t ) Page: 3 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! Tubular basophilia ! ! ! ! ! ! ! ! ! ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) ! ! Tubular dilatation with luminal hyaline substances ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) ! ! Interstitial mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) ! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 1 ! 1 ! 1 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Cortical fatty cytoplasmic vacuolation ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(50%)!(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(50%)!(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Accessory cortical nodule (rest) ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !TESTES ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 35 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 1 4 -d a y s t r e a t m e n t ) Page: 4 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! Epidermal hypertrophy/hyperplasia ! ! ! ! ! ! ! ! ! ! ! very slight ! 1 ! 1 ! 0 ! 1 ! 1 ! 0 ! 2 ! 2 ! 1 ! ! ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! slight ! 1 ! 1 ! 2 ! 1 ! 1 ! 2 ! 0 ! 0 ! 1 ! ! ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ! Score Expanded Totals ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Hyperkeratosis ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 1 ! 2 ! 1 ! 0 ! 2 ! 0 ! 0 ! 1 ! ! ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ! Score Expanded Totals ! 1 ! 1 ! 2 ! 1 ! 0 ! 2 ! 0 ! 0 ! 1 ! ! ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ! Dermal inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 1 ! 1 ! 0 ! 2 ! 0 ! 0 ! 0 ! ! ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 1 ! 0 ! 2 ! 0 ! 0 ! 0 ! ! ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 1 ! 2 ! 1 ! 2 ! 1 ! 1 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ! Ulcerative inflammation ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(50%)! ! moderate ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(50%)! ! Subcutaneous inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) ! ! Epidermal hyperplasia ! ! ! ! ! ! ! ! ! ! ! slight ! 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 36 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 1 4 -d a y s t r e a t m e n t ) Page: 5 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! Epidermal hyperplasia ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(50%)! ! Hyperkeratosis ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(50%)! ! moderate ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(50%)! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 2 ! 2 ! 1 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Myocardial mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 1 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Hepatodiaphragmatic nodule ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 37 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 1 4 -d a y s t r e a t m e n t ) Page: 6 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! 2 ! 1 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! Interstitial mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)! ! moderate ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(50%)! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !OVARIES ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 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 *** Listing Complete *** Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 38 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ Table 7: Summary of histopathological findings (28-days treatment) FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( 2 8 -d a y s t r e a t m e n t ) Page: 1 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 0 ! 0 ! 0 ! 1 ! 1 ! 1 ! 1 ! 1 ! ! !(50%)!(0%) !(0%) !(0%) !(50%)!(50%)!(50%)!(50%)!(50%)! ! Epidermal hypertrophy/hyperplasia ! 1 ! 2 ! 2 ! 2 ! 1 ! 1 ! 1 ! 1 ! 1 ! ! ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ! Hyperkeratosis ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(50%)! ! Ulcerative inflammation ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Dermal inflammatory cell infiltration ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 1 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! (Ulcerative) inflammation ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Epidermal hyperplasia ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Hyperkeratosis ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Dermal fibrosis ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 1 ! 1 ! 1 ! 2 ! 1 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Myocardial degeneration ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(0%) !(0%) ! ! Myocardial mononuclear cell infiltration ! 0 ! 0 ! 1 ! 1 ! 1 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(50%)!(50%)!(0%) !(50%)!(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 1 ! 1 ! 2 ! 2 ! 1 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 39 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( 2 8 -d a y s t r e a t m e n t ) Page: 2 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! Hepatocellular necrosis ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Granulation tissue ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Mononuclear cell infiltration ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(50%)!(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 1 ! 2 ! 2 ! 2 ! 1 ! 1 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ! Tubular basophilia ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(50%)!(0%) ! ! Tubular dilatation with luminal hyaline substances ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(50%)!(0%) ! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! Accessory cortical nodule (rest) ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)! ! ! ! ! ! ! ! ! ! ! ! !TESTES ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !CEREBRUM ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 40 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( 2 8 -d a y s t r e a t m e n t ) Page: 3 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! Epidermal hypertrophy/hyperplasia ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Hyperkeratosis ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 2 ! 0 ! ! ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ! Epidermal erosion(s) ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) ! ! Dermal inflammatory cell infiltration ! 0 ! 1 ! 0 ! 1 ! 1 ! 0 ! 0 ! 2 ! 0 ! ! ! ( 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 0 ! 2 ! 1 ! 1 ! 2 ! 1 ! 2 ! 2 ! 0 ! ! ! ( 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ! (Ulcerative) inflammation ! 1 ! 0 ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! 2 ! ! ! ( 5 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ! Epidermal erosion(s) ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Dermal inflammatory cell infiltration ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Subcutaneous inflammatory cell infiltration ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) ! ! Epidermal hyperplasia ! 2 ! 0 ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! 2 ! ! !( 1 0 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ! Hyperkeratosis ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 2 ! ! ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ! Haemorrhage ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 41 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ F R A U N H O F E R I TA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( 2 8 -d a y s t r e a t m e n t ) Page: 4 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! I N C I D E N C E O F L E S I O N S ( P E R C E N T) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! TR E A TM E N T !s a l i n e !T- !T- !T- !T- !T- !T- !T- !T- ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! Mononuclear cell infiltration ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 1 ! 2 ! 0 ! 1 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Tu b u l a r b a s o p h i l i a ! 0 ! 0 ! 1 ! 0 ! 1 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(50%)!(0%) !(0%) !(0%) ! ! Tu b u l a r d i l a t a t i o n w i t h l u m i n a l h y a l i n e s u b s t a n c e s ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !OVARIES ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! ! P I TU I TA R Y ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! Cyst(s) ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! A B D O M I N A L C A V I TY ! ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! Fat necrosis ! ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 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 *** Listing Complete *** Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 42 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ Table 8: Summary of histopathological findings (with scores, 28-days treatment) FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 2 8 -d a y s t r e a t m e n t ) Page: 1 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 0 ! 0 ! 0 ! 1 ! 1 ! 1 ! 1 ! 1 ! ! !(50%)!(0%) !(0%) !(0%) !(50%)!(50%)!(50%)!(50%)!(50%)! ! Epidermal hypertrophy/hyperplasia ! ! ! ! ! ! ! ! ! ! ! very slight ! 1 ! 1 ! 2 ! 0 ! 1 ! 1 ! 1 ! 1 ! 0 ! ! ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ! slight ! 0 ! 1 ! 0 ! 2 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! ! ( 0 % ) ! ( 5 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ! Score Expanded Totals ! 1 ! 2 ! 2 ! 2 ! 1 ! 1 ! 1 ! 1 ! 1 ! ! ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ! Hyperkeratosis ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(50%)! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(50%)! ! Ulcerative inflammation ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Dermal inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 1 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! (Ulcerative) inflammation ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Epidermal hyperplasia ! ! ! ! ! ! ! ! ! ! ! severe ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 43 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 2 8 -d a y s t r e a t m e n t ) Page: 2 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! Epidermal hyperplasia ! ! ! ! ! ! ! ! ! ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Hyperkeratosis ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Dermal fibrosis ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 1 ! 1 ! 1 ! 2 ! 1 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Myocardial degeneration ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(0%) !(0%) ! ! Myocardial mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! very slight ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! slight ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(50%)!(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 1 ! 1 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(50%)!(50%)!(0%) !(50%)!(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 1 ! 1 ! 2 ! 2 ! 1 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 44 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 2 8 -d a y s t r e a t m e n t ) Page: 3 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! Hepatocellular necrosis ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Granulation tissue ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) ! ! Mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(50%)!(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(50%)!(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 1 ! 2 ! 2 ! 2 ! 1 ! 1 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ! Tubular basophilia ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(50%)!(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(50%)!(0%) ! ! Tubular dilatation with luminal hyaline substances ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(50%)!(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(50%)!(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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 45 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 2 8 -d a y s t r e a t m e n t ) Page: 4 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! Accessory cortical nodule (rest) ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)! ! ! ! ! ! ! ! ! ! ! ! !TESTES ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !CEREBRUM ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 46 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 2 8 -d a y s t r e a t m e n t ) Page: 5 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! Epidermal hypertrophy/hyperplasia ! ! ! ! ! ! ! ! ! ! ! very slight ! 1 ! 1 ! 2 ! 2 ! 2 ! 2 ! 1 ! 0 ! 2 ! ! ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ! slight ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! 2 ! 0 ! ! ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ! Score Expanded Totals ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Hyperkeratosis ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 2 ! 0 ! ! ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 2 ! 0 ! ! ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ! Epidermal erosion(s) ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) ! ! Dermal inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 1 ! 0 ! 1 ! 1 ! 0 ! 0 ! 2 ! 0 ! ! ! ( 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ! Score Expanded Totals ! 0 ! 1 ! 0 ! 1 ! 1 ! 0 ! 0 ! 2 ! 0 ! ! ! ( 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 0 ! 2 ! 1 ! 1 ! 2 ! 1 ! 2 ! 2 ! 0 ! ! ! ( 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ! (Ulcerative) inflammation ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(50%)!(50%)!(0%) !(0%) !(0%) !(0%) !(50%)! ! severe ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)! ! Score Expanded Totals ! 1 ! 0 ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! 2 ! ! ! ( 5 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ! Epidermal erosion(s) ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 47 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 2 8 -d a y s t r e a t m e n t ) Page: 6 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! Epidermal erosion(s) ! ! ! ! ! ! ! ! ! ! ! Score Expanded Totals ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Dermal inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Subcutaneous inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) ! ! Epidermal hyperplasia ! ! ! ! ! ! ! ! ! ! ! moderate ! 2 ! 0 ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! 2 ! ! !( 1 0 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ! Score Expanded Totals ! 2 ! 0 ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! 2 ! ! !( 1 0 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ! Hyperkeratosis ! ! ! ! ! ! ! ! ! ! ! moderate ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 2 ! ! ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 2 ! ! ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ! Haemorrhage ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 48 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 2 8 -d a y s t r e a t m e n t ) Page: 7 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 1 ! 2 ! 0 ! 1 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Tubular basophilia ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 1 ! 0 ! 1 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(50%)!(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 1 ! 1 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(50%)!(0%) !(0%) !(0%) ! ! Tubular dilatation with luminal hyaline substances ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !OVARIES ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 49 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 2 8 -d a y s t r e a t m e n t ) Page: 8 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !PITUITARY ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! Cyst(s) ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !ABDOMINAL CAVITY ! ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! Fat necrosis ! ! ! 1 ! ! ! ! ! ! ! ! ! ! !( 1 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 *** Listing Complete *** Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 50 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ Table 9: Summary of histopathological findings (28-days treatment + 14 days recovery) FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( 2 8 -d a y s t r e a t m . + 1 4 -d a y s r e c o v . ) Page: 1 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 0 ! 1 ! 1 ! 1 ! 2 ! 1 ! 1 ! 1 ! 1 ! ! ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ! Epidermal hypertrophy/hyperplasia ! 2 ! 1 ! 1 ! 1 ! 0 ! 1 ! 1 ! 1 ! 1 ! ! !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ! Hyperkeratosis ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 1 ! 2 ! 2 ! 2 ! 2 ! 1 ! 2 ! 1 ! ! ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! Myocardial degeneration ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(50%)!(50%)!(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! Myocardial mononuclear cell infiltration ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! ! !(50%)!(50%)!(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(50%)! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 1 ! 2 ! 2 ! 2 ! 2 ! 1 ! 2 ! 2 ! ! ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Hepatodiaphragmatic nodule ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! Mononuclear cell infiltration ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 51 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( 2 8 -d a y s t r e a t m . + 1 4 -d a y s r e c o v . ) Page: 2 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 2 ! 1 ! 1 ! 0 ! 2 ! 1 ! 2 ! 0 ! ! ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ! Tubular basophilia ! 1 ! 0 ! 0 ! 1 ! 2 ! 0 ! 0 ! 0 ! 1 ! ! ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ! Tubular dilatation with luminal hyaline substances ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 1 ! 0 ! 1 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(50%)!(0%) !(50%)! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 1 ! 2 ! 1 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Cortical fatty cytoplasmic vacuolation ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !TESTES ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 52 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( 2 8 -d a y s t r e a t m . + 1 4 -d a y s r e c o v . ) Page: 3 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 0 ! 0 ! 1 ! 1 ! 1 ! 0 ! 0 ! 1 ! 2 ! ! ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ! Epidermal hypertrophy/hyperplasia ! 2 ! 2 ! 1 ! 1 ! 1 ! 2 ! 2 ! 1 ! 0 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Myocardial mononuclear cell infiltration ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 1 ! 2 ! 1 ! 2 ! 1 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Mononuclear cell infiltration ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(50%)!(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 1 ! 1 ! 2 ! 2 ! 2 ! 0 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ! Tubular basophilia ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(50%)! ! Tubular dilatation with luminal hyaline substances ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 2 ! ! ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 53 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( 2 8 -d a y s t r e a t m . + 1 4 -d a y s r e c o v . ) Page: 4 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! Accessory cortical nodule (rest) ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)! ! ! ! ! ! ! ! ! ! ! ! !OVARIES ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! Cyst(s) ! 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] Page 54 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ Table 10: Summary of histopathological findings (with scores, 28-days treatment + 14 days recovery) FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 2 8 -d a y s t r e a t m . + 1 4 -d a y s r e c o v . ) Page: 1 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 0 ! 1 ! 1 ! 1 ! 2 ! 1 ! 1 ! 1 ! 1 ! ! ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ! Epidermal hypertrophy/hyperplasia ! ! ! ! ! ! ! ! ! ! ! very slight ! 2 ! 1 ! 1 ! 1 ! 0 ! 1 ! 1 ! 1 ! 1 ! ! !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ! Score Expanded Totals ! 2 ! 1 ! 1 ! 1 ! 0 ! 1 ! 1 ! 1 ! 1 ! ! !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ! Hyperkeratosis ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 1 ! 2 ! 2 ! 2 ! 2 ! 1 ! 2 ! 1 ! ! ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! Myocardial degeneration ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(50%)!(50%)!(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! Score Expanded Totals ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(50%)!(50%)!(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! Myocardial mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! ! !(50%)!(50%)!(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(50%)! ! Score Expanded Totals ! 1 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 1 ! ! !(50%)!(50%)!(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(50%)! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 1 ! 2 ! 2 ! 2 ! 2 ! 1 ! 2 ! 2 ! ! ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 55 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 2 8 -d a y s t r e a t m . + 1 4 -d a y s r e c o v . ) Page: 2 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! Hepatodiaphragmatic nodule ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(50%)!(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! Mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 1 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! ! !(50%)!(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 1 ! 2 ! 1 ! 1 ! 0 ! 2 ! 1 ! 2 ! 0 ! ! ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ! Tubular basophilia ! ! ! ! ! ! ! ! ! ! ! slight ! 1 ! 0 ! 0 ! 1 ! 2 ! 0 ! 0 ! 0 ! 1 ! ! ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ! Score Expanded Totals ! 1 ! 0 ! 0 ! 1 ! 2 ! 0 ! 0 ! 0 ! 1 ! ! ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ! Tubular dilatation with luminal hyaline substances ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 1 ! 0 ! 1 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(50%)!(0%) !(50%)! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 1 ! 0 ! 1 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(50%)!(0%) !(50%)! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 1 ! 2 ! 1 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Cortical fatty cytoplasmic vacuolation ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(0%) !(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 56 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 2 8 -d a y s t r e a t m . + 1 4 -d a y s r e c o v . ) Page: 3 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !TESTES ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 57 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 2 8 -d a y s t r e a t m . + 1 4 -d a y s r e c o v . ) Page: 4 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 0 ! 0 ! 1 ! 1 ! 1 ! 0 ! 0 ! 1 ! 2 ! ! ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ! Epidermal hypertrophy/hyperplasia ! ! ! ! ! ! ! ! ! ! ! very slight ! 2 ! 2 ! 1 ! 1 ! 1 ! 2 ! 2 ! 1 ! 0 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ! Score Expanded Totals ! 2 ! 2 ! 1 ! 1 ! 1 ! 2 ! 2 ! 1 ! 0 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Myocardial mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 1 ! 2 ! 1 ! 2 ! 1 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ! Mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(50%)!(0%) !(0%) ! ! Score Expanded Totals ! 0 ! 0 ! 1 ! 0 ! 1 ! 0 ! 1 ! 0 ! 0 ! ! !(0%) !(0%) !(50%)!(0%) !(50%)!(0%) !(50%)!(0%) !(0%) ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 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 *** Continued Fraunhofer ITEM Final Report 01 G 00 0 02 [Appendix E] Page 58 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 S u m m a r y o f h i s t o p a t h o l o g i c a l f i n d i n g s ( w i t h s c o r e s , 2 8 -d a y s t r e a t m . + 1 4 -d a y s r e c o v . ) Page: 5 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (PERCENT) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 1 ! 1 ! 2 ! 2 ! 2 ! 0 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ( 5 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 0 % ) ! ! Tubular basophilia ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(50%)! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(50%)!(0%) !(0%) !(0%) !(50%)! ! Tubular dilatation with luminal hyaline substances ! ! ! ! ! ! ! ! ! ! ! slight ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 2 ! ! ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ! Score Expanded Totals ! 0 ! 0 ! 0 ! 1 ! 0 ! 0 ! 0 ! 0 ! 2 ! ! ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 5 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) ! ( 0 % ) !( 1 0 0 % ) ! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! Accessory cortical nodule (rest) ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 0 ! 1 ! ! !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(0%) !(50%)! ! ! ! ! ! ! ! ! ! ! ! !OVARIES ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! (2) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 2 ! 1 ! ! !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) !( 1 0 0 % ) ! ( 5 0 % ) ! ! Cyst(s) ! 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] Page 59 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ Table 11: Histopathological findings of Individual Animals FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 1 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (ANIMAL REFERENCES) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected !0 1 0 0 0 4 !0 3 0 0 0 8 !0 5 0 0 0 1 !0 7 0 0 0 7 !0 9 0 0 0 2 !1 1 0 0 0 6 !1 3 0 0 0 6 !1 5 0 0 0 1 !1 7 0 0 0 4 ! ! !0 1 0 0 0 6 ! !0 5 0 0 0 7 ! !0 9 0 0 0 6 !1 1 0 0 0 7 !1 3 0 0 0 7 !1 5 0 0 0 5 !1 7 0 0 0 5 ! ! ! ! ! ! !0 9 0 0 0 7 ! ! !1 5 0 0 0 8 !1 7 0 0 0 7 ! ! ! ! ! ! !0 9 0 0 0 8 ! ! ! ! ! ! Epidermal hypertrophy/hyperplasia ! ! ! ! ! ! ! ! ! ! ! very slight !0 1 0 0 0 1 !0 3 0 0 0 1 !0 5 0 0 0 2 !0 7 0 0 0 2 !0 9 0 0 0 1 !1 1 0 0 0 1 !1 3 0 0 0 2 !1 5 0 0 0 2 !1 7 0 0 0 2 ! ! !0 1 0 0 0 2 !0 3 0 0 0 2 !0 5 0 0 0 3 !0 7 0 0 0 3 !0 9 0 0 0 3 !1 1 0 0 0 2 !1 3 0 0 0 3 !1 5 0 0 0 3 !1 7 0 0 0 3 ! ! !0 1 0 0 0 3 !0 3 0 0 0 3 !0 5 0 0 0 5 !0 7 0 0 0 4 !0 9 0 0 0 4 !1 1 0 0 0 4 !1 3 0 0 0 4 !1 5 0 0 0 4 !1 7 0 0 0 8 ! ! !0 1 0 0 0 5 !0 3 0 0 0 4 !0 5 0 0 0 6 !0 7 0 0 0 8 !0 9 0 0 0 5 !1 1 0 0 0 5 !1 3 0 0 0 5 !1 5 0 0 0 6 ! ! ! !0 1 0 0 0 7 !0 3 0 0 0 6 !0 5 0 0 0 8 ! ! !1 1 0 0 0 8 !1 3 0 0 0 8 !1 5 0 0 0 7 ! ! ! !0 1 0 0 0 8 !0 3 0 0 0 7 ! ! ! ! ! ! ! ! ! slight ! !0 3 0 0 0 5 !0 5 0 0 0 4 !0 7 0 0 0 1 ! !1 1 0 0 0 3 !1 3 0 0 0 1 ! !1 7 0 0 0 1 ! ! ! ! ! !0 7 0 0 0 5 ! ! ! ! !1 7 0 0 0 6 ! ! ! ! ! !0 7 0 0 0 6 ! ! ! ! ! ! ! Multifocal hyperkeratosis ! ! ! ! ! ! ! ! ! ! ! slight ! !0 3 0 0 0 7 !0 5 0 0 0 4 !0 7 0 0 0 5 !0 9 0 0 0 1 !1 1 0 0 0 3 ! ! !1 7 0 0 0 6 ! ! Focal hyperkeratosis ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! ! ! ! !1 7 0 0 0 1 ! ! Focal ulcerative inflammation ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! !0 7 0 0 0 5 ! ! ! ! ! ! ! Focal epidermal erosion(s) ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! !1 1 0 0 0 2 ! ! ! ! ! Multifocal dermal inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! very slight ! !0 3 0 0 0 3 !0 5 0 0 0 3 ! ! ! ! ! ! ! ! ! !0 3 0 0 0 4 ! ! ! ! ! ! ! ! ! slight ! !0 3 0 0 0 5 ! !0 7 0 0 0 6 ! ! ! ! ! ! ! Focal dermal inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! !0 7 0 0 0 4 !0 9 0 0 0 4 !1 1 0 0 0 2 ! ! !1 7 0 0 0 1 ! ! Focal subcutaneous inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! moderate ! ! ! ! ! ! !1 3 0 0 0 1 ! ! ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected !0 1 0 0 0 1 !0 3 0 0 0 1 !0 5 0 0 0 1 !0 7 0 0 0 1 !0 9 0 0 0 1 !1 1 0 0 0 1 !1 3 0 0 0 1 !1 5 0 0 0 1 !1 7 0 0 0 1 ! ! !0 1 0 0 0 2 !0 3 0 0 0 2 !0 5 0 0 0 2 !0 7 0 0 0 2 !0 9 0 0 0 2 !1 1 0 0 0 2 !1 3 0 0 0 2 !1 5 0 0 0 2 !1 7 0 0 0 2 ! ! !0 1 0 0 0 3 !0 3 0 0 0 3 !0 5 0 0 0 3 !0 7 0 0 0 3 !0 9 0 0 0 3 !1 1 0 0 0 3 !1 3 0 0 0 3 !1 5 0 0 0 3 !1 7 0 0 0 3 ! ! !0 1 0 0 0 4 !0 3 0 0 0 4 !0 5 0 0 0 4 !0 7 0 0 0 4 !0 9 0 0 0 4 !1 1 0 0 0 4 !1 3 0 0 0 5 !1 5 0 0 0 4 !1 7 0 0 0 4 ! ! !0 1 0 0 0 5 !0 3 0 0 0 5 !0 5 0 0 0 6 !0 7 0 0 0 5 !0 9 0 0 0 5 !1 1 0 0 0 5 !1 3 0 0 0 6 !1 5 0 0 0 5 !1 7 0 0 0 5 ! ! ! ! ! ! ! ! ! ! ! ! -------------------------------------------------------------------------------------------------------------------------- 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] Page 60 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 2 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (ANIMAL REFERENCES) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! No abnormality detected !0 1 0 0 0 6 !0 3 0 0 0 6 !0 5 0 0 0 7 !0 7 0 0 0 6 !0 9 0 0 0 6 !1 1 0 0 0 6 !1 3 0 0 0 7 !1 5 0 0 0 6 !1 7 0 0 0 6 ! ! !0 1 0 0 0 7 !0 3 0 0 0 7 !0 5 0 0 0 8 !0 7 0 0 0 7 !0 9 0 0 0 7 !1 1 0 0 0 7 !1 3 0 0 0 8 !1 5 0 0 0 7 !1 7 0 0 0 7 ! ! !0 1 0 0 0 8 !0 3 0 0 0 8 ! !0 7 0 0 0 8 !0 9 0 0 0 8 !1 1 0 0 0 8 ! !1 5 0 0 0 8 !1 7 0 0 0 8 ! ! Focal ulcerative inflammation : due to ! ! ! ! ! ! ! ! ! ! ! mechanical irritation ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! ! !1 3 0 0 0 4 ! ! ! ! Focal inflammation : due to mechanical irritation ! ! ! ! ! ! ! ! ! ! ! moderate ! ! !0 5 0 0 0 5 ! ! ! ! ! ! ! ! Focal epidermal hyperplasia : due to mechanical ! ! ! ! ! ! ! ! ! ! ! irritation ! ! ! ! ! ! ! ! ! ! ! moderate ! ! ! ! ! ! !1 3 0 0 0 4 ! ! ! ! severe ! ! !0 5 0 0 0 5 ! ! ! ! ! ! ! ! Focal hyperkeratosis : due to mechanical ! ! ! ! ! ! ! ! ! ! ! irritation ! ! ! ! ! ! ! ! ! ! ! moderate ! ! !0 5 0 0 0 5 ! ! ! ! ! ! ! ! Focal dermal fibrosis : due to mechanical ! ! ! ! ! ! ! ! ! ! ! irritation ! ! ! ! ! ! ! ! ! ! ! moderate ! ! !0 5 0 0 0 5 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !CEREBRUM ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected !0 1 0 0 0 6 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected !0 1 0 0 0 1 !0 3 0 0 0 1 !0 5 0 0 0 1 !0 7 0 0 0 1 !0 9 0 0 0 1 !1 1 0 0 0 1 !1 3 0 0 0 1 !1 5 0 0 0 1 !1 7 0 0 0 1 ! ! !0 1 0 0 0 2 !0 3 0 0 0 2 !0 5 0 0 0 2 !0 7 0 0 0 2 !0 9 0 0 0 2 !1 1 0 0 0 2 !1 3 0 0 0 2 !1 5 0 0 0 2 !1 7 0 0 0 2 ! ! !0 1 0 0 0 3 !0 3 0 0 0 3 !0 5 0 0 0 3 !0 7 0 0 0 3 !0 9 0 0 0 3 !1 1 0 0 0 3 !1 3 0 0 0 3 !1 5 0 0 0 3 !1 7 0 0 0 4 ! ! !0 1 0 0 0 4 !0 3 0 0 0 4 !0 5 0 0 0 5 !0 7 0 0 0 4 !0 9 0 0 0 4 !1 1 0 0 0 4 !1 3 0 0 0 4 !1 5 0 0 0 4 !1 7 0 0 0 5 ! ! !0 1 0 0 0 5 !0 3 0 0 0 5 !0 5 0 0 0 7 !0 7 0 0 0 5 !0 9 0 0 0 5 !1 1 0 0 0 5 !1 3 0 0 0 6 !1 5 0 0 0 5 !1 7 0 0 0 6 ! ! !0 1 0 0 0 6 !0 3 0 0 0 6 !0 5 0 0 0 8 !0 7 0 0 0 7 !0 9 0 0 0 7 !1 1 0 0 0 6 !1 3 0 0 0 7 !1 5 0 0 0 6 !1 7 0 0 0 8 ! ! !0 1 0 0 0 8 !0 3 0 0 0 7 ! !0 7 0 0 0 8 !0 9 0 0 0 8 !1 1 0 0 0 7 ! !1 5 0 0 0 7 ! ! ! ! ! ! ! ! !1 1 0 0 0 8 ! !1 5 0 0 0 8 ! ! ! Focal myocardial degeneration ! ! ! ! ! ! ! ! ! ! ! slight !0 1 0 0 0 7 !0 3 0 0 0 8 !0 5 0 0 0 6 ! !0 9 0 0 0 6 ! !1 3 0 0 0 8 ! ! ! ! Focal myocardial mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! very slight ! ! !0 5 0 0 0 4 !0 7 0 0 0 6 ! ! ! ! ! ! ! slight !0 1 0 0 0 7 !0 3 0 0 0 8 !0 5 0 0 0 6 ! !0 9 0 0 0 6 ! !1 3 0 0 0 5 ! !1 7 0 0 0 3 ! ! ! ! ! ! ! ! !1 3 0 0 0 8 ! !1 7 0 0 0 7 ! ! ! ! ! ! ! ! ! ! ! ! -------------------------------------------------------------------------------------------------------------------------- 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] Page 61 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 3 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (ANIMAL REFERENCES) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected !0 1 0 0 0 1 !0 3 0 0 0 1 !0 5 0 0 0 1 !0 7 0 0 0 1 !0 9 0 0 0 1 !1 1 0 0 0 1 !1 3 0 0 0 1 !1 5 0 0 0 1 !1 7 0 0 0 1 ! ! !0 1 0 0 0 2 !0 3 0 0 0 2 !0 5 0 0 0 2 !0 7 0 0 0 2 !0 9 0 0 0 2 !1 1 0 0 0 2 !1 3 0 0 0 2 !1 5 0 0 0 2 !1 7 0 0 0 2 ! ! !0 1 0 0 0 3 !0 3 0 0 0 3 !0 5 0 0 0 3 !0 7 0 0 0 3 !0 9 0 0 0 3 !1 1 0 0 0 3 !1 3 0 0 0 3 !1 5 0 0 0 3 !1 7 0 0 0 3 ! ! !0 1 0 0 0 5 !0 3 0 0 0 4 !0 5 0 0 0 5 !0 7 0 0 0 4 !0 9 0 0 0 6 !1 1 0 0 0 4 !1 3 0 0 0 4 !1 5 0 0 0 6 !1 7 0 0 0 4 ! ! !0 1 0 0 0 6 !0 3 0 0 0 5 !0 5 0 0 0 6 !0 7 0 0 0 6 !0 9 0 0 0 7 !1 1 0 0 0 5 !1 3 0 0 0 5 !1 5 0 0 0 7 !1 7 0 0 0 5 ! ! !0 1 0 0 0 7 !0 3 0 0 0 6 !0 5 0 0 0 7 !0 7 0 0 0 7 !0 9 0 0 0 8 !1 1 0 0 0 6 !1 3 0 0 0 6 !1 5 0 0 0 8 !1 7 0 0 0 6 ! ! ! !0 3 0 0 0 7 !0 5 0 0 0 8 !0 7 0 0 0 8 ! !1 1 0 0 0 7 !1 3 0 0 0 7 ! !1 7 0 0 0 7 ! ! ! ! ! ! ! !1 1 0 0 0 8 ! ! !1 7 0 0 0 8 ! ! Hepatodiaphragmatic nodule ! !0 3 0 0 0 8 ! ! ! ! !1 3 0 0 0 8 ! ! ! ! Focal hepatocellular necrosis ! ! ! ! ! ! ! ! ! ! ! moderate ! ! ! !0 7 0 0 0 5 ! ! ! ! ! ! ! Focal granulation tissue ! ! ! ! ! ! ! ! ! ! ! moderate ! ! ! !0 7 0 0 0 5 ! ! ! ! ! ! ! Multifocal mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight !0 1 0 0 0 4 ! ! ! ! ! ! !1 5 0 0 0 5 ! ! ! !0 1 0 0 0 8 ! ! ! ! ! ! ! ! ! ! Focal mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! ! !0 5 0 0 0 4 ! !0 9 0 0 0 4 ! ! !1 5 0 0 0 4 ! ! ! ! ! ! ! !0 9 0 0 0 5 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected !0 1 0 0 0 2 !0 3 0 0 0 1 !0 5 0 0 0 1 !0 7 0 0 0 1 !0 9 0 0 0 2 !1 1 0 0 0 2 !1 3 0 0 0 1 !1 5 0 0 0 1 !1 7 0 0 0 1 ! ! !0 1 0 0 0 3 !0 3 0 0 0 2 !0 5 0 0 0 3 !0 7 0 0 0 2 !0 9 0 0 0 4 !1 1 0 0 0 3 !1 3 0 0 0 2 !1 5 0 0 0 2 !1 7 0 0 0 2 ! ! !0 1 0 0 0 4 !0 3 0 0 0 3 !0 5 0 0 0 5 !0 7 0 0 0 3 !0 9 0 0 0 5 !1 1 0 0 0 4 !1 3 0 0 0 3 !1 5 0 0 0 6 !1 7 0 0 0 3 ! ! !0 1 0 0 0 5 !0 3 0 0 0 4 !0 5 0 0 0 8 !0 7 0 0 0 4 !0 9 0 0 0 6 !1 1 0 0 0 5 !1 3 0 0 0 4 !1 5 0 0 0 7 !1 7 0 0 0 4 ! ! !0 1 0 0 0 6 !0 3 0 0 0 5 ! !0 7 0 0 0 5 ! !1 1 0 0 0 6 !1 3 0 0 0 6 !1 5 0 0 0 8 !1 7 0 0 0 5 ! ! !0 1 0 0 0 7 !0 3 0 0 0 6 ! !0 7 0 0 0 6 ! !1 1 0 0 0 7 !1 3 0 0 0 8 ! !1 7 0 0 0 6 ! ! ! !0 3 0 0 0 7 ! !0 7 0 0 0 7 ! !1 1 0 0 0 8 ! ! ! ! ! ! !0 3 0 0 0 8 ! ! ! ! ! ! ! ! ! Multifocal tubular dilatation with luminal ! ! ! ! ! ! ! ! ! ! ! hyaline substances ! ! ! ! ! ! ! ! ! ! ! slight ! ! !0 5 0 0 0 7 ! !0 9 0 0 0 8 !1 1 0 0 0 1 ! ! !1 7 0 0 0 7 ! ! U n i -l a t e r a l m u l t i f o c a l t u b u l a r d i l a t a t i o n w i t h ! ! ! ! ! ! ! ! ! ! ! luminal hyaline substances ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! ! !1 3 0 0 0 5 !1 5 0 0 0 3 ! ! ! ! ! ! ! ! ! ! ! ! ! -------------------------------------------------------------------------------------------------------------------------- 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] Page 62 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 4 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (ANIMAL REFERENCES) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! U n i -l a t e r a l f o c a l t u b u l a r d i l a t a t i o n w i t h ! ! ! ! ! ! ! ! ! ! ! luminal hyaline substances ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! ! !1 3 0 0 0 7 !1 5 0 0 0 5 ! ! ! U n i -l a t e r a l f o c a l i n t e r s t i t i a l m o n o n u c l e a r c e l l ! ! ! ! ! ! ! ! ! ! ! infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! ! ! !1 5 0 0 0 4 ! ! ! U n i -l a t e r a l f o c a l c o r t i c a l s c a r ( s ) ! ! ! ! ! ! ! ! ! ! ! slight ! ! !0 5 0 0 0 2 ! ! ! ! ! ! ! ! U n i -l a t e r a l f o c a l t u b u l a r -c e l l d e g e n e r a t i o n ! ! ! ! ! ! ! ! ! ! ! slight ! ! !0 5 0 0 0 4 ! ! ! ! ! ! ! ! Multifocal tubular basophilia ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! !0 9 0 0 0 8 ! ! ! !1 7 0 0 0 8 ! ! U n i -l a t e r a l m u l t i f o c a l t u b u l a r b a s o p h i l i a ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! ! ! !1 5 0 0 0 5 ! ! ! U n i -l a t e r a l f o c a l t u b u l a r b a s o p h i l i a ! ! ! ! ! ! ! ! ! ! ! very slight !0 1 0 0 0 1 ! ! ! ! ! ! ! ! ! ! slight !0 1 0 0 0 8 ! !0 5 0 0 0 6 !0 7 0 0 0 8 !0 9 0 0 0 1 ! ! ! ! ! ! ! ! ! ! !0 9 0 0 0 3 ! ! ! ! ! ! ! ! ! ! !0 9 0 0 0 7 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected !0 1 0 0 0 1 !0 3 0 0 0 1 !0 5 0 0 0 1 !0 7 0 0 0 2 !0 9 0 0 0 1 !1 1 0 0 0 1 !1 3 0 0 0 1 !1 5 0 0 0 1 !1 7 0 0 0 1 ! ! !0 1 0 0 0 3 !0 3 0 0 0 2 !0 5 0 0 0 3 !0 7 0 0 0 4 !0 9 0 0 0 2 !1 1 0 0 0 2 !1 3 0 0 0 2 !1 5 0 0 0 2 !1 7 0 0 0 2 ! ! !0 1 0 0 0 4 !0 3 0 0 0 4 !0 5 0 0 0 5 !0 7 0 0 0 5 !0 9 0 0 0 3 !1 1 0 0 0 3 !1 3 0 0 0 3 !1 5 0 0 0 3 !1 7 0 0 0 3 ! ! !0 1 0 0 0 5 !0 3 0 0 0 5 !0 5 0 0 0 6 !0 7 0 0 0 6 !0 9 0 0 0 4 !1 1 0 0 0 4 !1 3 0 0 0 4 !1 5 0 0 0 4 !1 7 0 0 0 4 ! ! !0 1 0 0 0 6 !0 3 0 0 0 6 !0 5 0 0 0 8 !0 7 0 0 0 7 !0 9 0 0 0 5 !1 1 0 0 0 5 !1 3 0 0 0 5 !1 5 0 0 0 5 !1 7 0 0 0 6 ! ! !0 1 0 0 0 7 !0 3 0 0 0 7 ! !0 7 0 0 0 8 !0 9 0 0 0 6 !1 1 0 0 0 6 !1 3 0 0 0 6 !1 5 0 0 0 6 !1 7 0 0 0 7 ! ! !0 1 0 0 0 8 !0 3 0 0 0 8 ! ! !0 9 0 0 0 7 !1 1 0 0 0 7 !1 3 0 0 0 7 !1 5 0 0 0 7 !1 7 0 0 0 8 ! ! ! ! ! ! ! !1 1 0 0 0 8 !1 3 0 0 0 8 !1 5 0 0 0 8 ! ! ! U n i -l a t e r a l a c c e s s o r y c o r t i c a l n o d u l e ( r e s t ) ! ! ! !0 7 0 0 0 1 ! ! ! ! !1 7 0 0 0 5 ! ! ! ! ! !0 7 0 0 0 3 ! ! ! ! ! ! ! Diffuse cortical fatty cytoplasmic vacuolation ! ! ! ! ! ! ! ! ! ! ! slight !0 1 0 0 0 2 ! !0 5 0 0 0 2 ! !0 9 0 0 0 8 ! ! ! ! ! ! ! ! !0 5 0 0 0 4 ! ! ! ! ! ! ! ! Multifocal cortical fatty cytoplasmic vacuolation ! ! ! ! ! ! ! ! ! ! ! slight ! ! !0 5 0 0 0 7 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! -------------------------------------------------------------------------------------------------------------------------- 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] Page 63 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 5 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (ANIMAL REFERENCES) ! ! !--------------------------------------------------------------! ! ! Males ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! U n i -l a t e r a l f o c a l c o r t i c a l f a t t y c y t o p l a s m i c ! ! ! ! ! ! ! ! ! ! ! vacuolation ! ! ! ! ! ! ! ! ! ! ! slight ! !0 3 0 0 0 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !TESTES ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected !0 1 0 0 0 1 !0 3 0 0 0 1 !0 5 0 0 0 1 !0 7 0 0 0 1 !0 9 0 0 0 1 !1 1 0 0 0 1 !1 3 0 0 0 1 !1 5 0 0 0 1 !1 7 0 0 0 1 ! ! !0 1 0 0 0 2 !0 3 0 0 0 2 !0 5 0 0 0 2 !0 7 0 0 0 2 !0 9 0 0 0 2 !1 1 0 0 0 2 !1 3 0 0 0 2 !1 5 0 0 0 2 !1 7 0 0 0 2 ! ! !0 1 0 0 0 3 !0 3 0 0 0 3 !0 5 0 0 0 3 !0 7 0 0 0 3 !0 9 0 0 0 3 !1 1 0 0 0 3 !1 3 0 0 0 3 !1 5 0 0 0 3 !1 7 0 0 0 3 ! ! !0 1 0 0 0 4 !0 3 0 0 0 4 !0 5 0 0 0 4 !0 7 0 0 0 4 !0 9 0 0 0 4 !1 1 0 0 0 4 !1 3 0 0 0 4 !1 5 0 0 0 4 !1 7 0 0 0 4 ! ! !0 1 0 0 0 5 !0 3 0 0 0 5 !0 5 0 0 0 5 !0 7 0 0 0 5 !0 9 0 0 0 5 !1 1 0 0 0 5 !1 3 0 0 0 5 !1 5 0 0 0 5 !1 7 0 0 0 5 ! ! !0 1 0 0 0 6 !0 3 0 0 0 6 !0 5 0 0 0 6 !0 7 0 0 0 6 !0 9 0 0 0 6 !1 1 0 0 0 6 !1 3 0 0 0 6 !1 5 0 0 0 6 !1 7 0 0 0 6 ! ! !0 1 0 0 0 7 !0 3 0 0 0 7 !0 5 0 0 0 7 !0 7 0 0 0 7 !0 9 0 0 0 7 !1 1 0 0 0 7 !1 3 0 0 0 7 !1 5 0 0 0 7 !1 7 0 0 0 7 ! ! !0 1 0 0 0 8 !0 3 0 0 0 8 !0 5 0 0 0 8 !0 7 0 0 0 8 !0 9 0 0 0 8 !1 1 0 0 0 8 !1 3 0 0 0 8 !1 5 0 0 0 8 !1 7 0 0 0 8 ! ! ! ! ! ! ! ! ! ! ! ! !THYMUS ! ! ! ! ! ! ! ! (1) ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! Multifocal haemorrhage ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! ! ! !1 5 0 0 0 2 ! ! ! Focal haemorrhage ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! ! ! ! !1 7 0 0 0 1 ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected !0 1 0 0 0 1 !0 3 0 0 0 1 !0 5 0 0 0 1 !0 7 0 0 0 1 !0 9 0 0 0 1 !1 1 0 0 0 1 !1 3 0 0 0 1 !1 5 0 0 0 1 !1 7 0 0 0 1 ! ! !0 1 0 0 0 2 !0 3 0 0 0 2 !0 5 0 0 0 2 !0 7 0 0 0 2 !0 9 0 0 0 2 !1 1 0 0 0 2 !1 3 0 0 0 2 !1 5 0 0 0 2 !1 7 0 0 0 2 ! ! !0 1 0 0 0 3 !0 3 0 0 0 3 !0 5 0 0 0 3 !0 7 0 0 0 3 !0 9 0 0 0 3 !1 1 0 0 0 3 !1 3 0 0 0 3 !1 5 0 0 0 3 !1 7 0 0 0 3 ! ! !0 1 0 0 0 4 !0 3 0 0 0 4 !0 5 0 0 0 4 !0 7 0 0 0 4 !0 9 0 0 0 4 !1 1 0 0 0 4 !1 3 0 0 0 4 !1 5 0 0 0 4 !1 7 0 0 0 4 ! ! !0 1 0 0 0 5 !0 3 0 0 0 5 !0 5 0 0 0 5 !0 7 0 0 0 5 !0 9 0 0 0 5 !1 1 0 0 0 5 !1 3 0 0 0 5 !1 5 0 0 0 5 !1 7 0 0 0 5 ! ! !0 1 0 0 0 6 !0 3 0 0 0 6 !0 5 0 0 0 6 !0 7 0 0 0 6 !0 9 0 0 0 6 !1 1 0 0 0 6 !1 3 0 0 0 6 !1 5 0 0 0 6 !1 7 0 0 0 6 ! ! !0 1 0 0 0 7 !0 3 0 0 0 7 !0 5 0 0 0 7 !0 7 0 0 0 7 !0 9 0 0 0 7 !1 1 0 0 0 7 !1 3 0 0 0 7 !1 5 0 0 0 7 !1 7 0 0 0 7 ! ! !0 1 0 0 0 8 !0 3 0 0 0 8 !0 5 0 0 0 8 !0 7 0 0 0 8 !0 9 0 0 0 8 !1 1 0 0 0 8 !1 3 0 0 0 8 !1 5 0 0 0 8 !1 7 0 0 0 8 ! ! ! ! ! ! ! ! ! ! ! ! -------------------------------------------------------------------------------------------------------------------------- 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] Page 64 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 6 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (ANIMAL REFERENCES) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (TREATED SITE) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! ! !0 6 0 0 0 1 !0 8 0 0 0 7 !1 0 0 0 0 8 ! ! !1 6 0 0 0 8 !1 8 0 0 0 7 ! ! ! ! !0 6 0 0 0 7 ! ! ! ! ! !1 8 0 0 0 8 ! ! Epidermal hypertrophy/hyperplasia ! ! ! ! ! ! ! ! ! ! ! very slight !0 2 0 0 0 3 !0 4 0 0 0 1 !0 6 0 0 0 2 !0 8 0 0 0 1 !1 0 0 0 0 1 !1 2 0 0 0 2 !1 4 0 0 0 1 !1 6 0 0 0 1 !1 8 0 0 0 1 ! ! !0 2 0 0 0 6 !0 4 0 0 0 2 !0 6 0 0 0 5 !0 8 0 0 0 2 !1 0 0 0 0 2 !1 2 0 0 0 5 !1 4 0 0 0 2 !1 6 0 0 0 2 !1 8 0 0 0 2 ! ! !0 2 0 0 0 7 !0 4 0 0 0 4 !0 6 0 0 0 6 !0 8 0 0 0 4 !1 0 0 0 0 3 !1 2 0 0 0 6 !1 4 0 0 0 3 !1 6 0 0 0 3 !1 8 0 0 0 3 ! ! !0 2 0 0 0 8 !0 4 0 0 0 6 !0 6 0 0 0 8 !0 8 0 0 0 5 !1 0 0 0 0 5 !1 2 0 0 0 7 !1 4 0 0 0 4 !1 6 0 0 0 4 !1 8 0 0 0 5 ! ! ! !0 4 0 0 0 7 ! !0 8 0 0 0 6 !1 0 0 0 0 6 !1 2 0 0 0 8 !1 4 0 0 0 5 !1 6 0 0 0 7 !1 8 0 0 0 6 ! ! ! !0 4 0 0 0 8 ! !0 8 0 0 0 8 !1 0 0 0 0 7 ! !1 4 0 0 0 7 ! ! ! ! ! ! ! ! ! ! !1 4 0 0 0 8 ! ! ! ! slight !0 2 0 0 0 1 !0 4 0 0 0 3 !0 6 0 0 0 3 !0 8 0 0 0 3 !1 0 0 0 0 4 !1 2 0 0 0 1 !1 4 0 0 0 6 !1 6 0 0 0 5 !1 8 0 0 0 4 ! ! !0 2 0 0 0 2 !0 4 0 0 0 5 !0 6 0 0 0 4 ! ! !1 2 0 0 0 3 ! !1 6 0 0 0 6 ! ! ! !0 2 0 0 0 4 ! ! ! ! !1 2 0 0 0 4 ! ! ! ! ! !0 2 0 0 0 5 ! ! ! ! ! ! ! ! ! ! Multifocal hyperkeratosis ! ! ! ! ! ! ! ! ! ! ! slight !0 2 0 0 0 1 !0 4 0 0 0 3 !0 6 0 0 0 3 !0 8 0 0 0 3 !1 0 0 0 0 2 !1 2 0 0 0 1 !1 4 0 0 0 2 !1 6 0 0 0 5 !1 8 0 0 0 4 ! ! !0 2 0 0 0 4 ! !0 6 0 0 0 4 !0 8 0 0 0 6 ! !1 2 0 0 0 3 ! !1 6 0 0 0 6 ! ! ! ! ! ! ! ! !1 2 0 0 0 4 ! ! ! ! ! Focal epidermal erosion(s) ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! ! ! !1 6 0 0 0 5 ! ! ! Multifocal dermal inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! very slight !0 2 0 0 0 1 ! ! ! ! ! ! ! ! ! ! !0 2 0 0 0 2 ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! ! ! !1 6 0 0 0 5 ! ! ! Focal dermal inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! !0 4 0 0 0 5 !0 6 0 0 0 3 !0 8 0 0 0 3 !1 0 0 0 0 5 !1 2 0 0 0 3 ! !1 6 0 0 0 6 ! ! ! ! ! ! !0 8 0 0 0 6 ! !1 2 0 0 0 4 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected !0 2 0 0 0 1 !0 4 0 0 0 1 !0 6 0 0 0 1 !0 8 0 0 0 1 !1 0 0 0 0 1 !1 2 0 0 0 1 !1 4 0 0 0 1 !1 6 0 0 0 1 !1 8 0 0 0 1 ! ! !0 2 0 0 0 2 !0 4 0 0 0 2 !0 6 0 0 0 2 !0 8 0 0 0 2 !1 0 0 0 0 2 !1 2 0 0 0 2 !1 4 0 0 0 2 !1 6 0 0 0 2 !1 8 0 0 0 2 ! ! !0 2 0 0 0 3 !0 4 0 0 0 3 !0 6 0 0 0 3 !0 8 0 0 0 4 !1 0 0 0 0 3 !1 2 0 0 0 4 !1 4 0 0 0 3 !1 6 0 0 0 3 !1 8 0 0 0 3 ! ! !0 2 0 0 0 4 !0 4 0 0 0 4 !0 6 0 0 0 4 !0 8 0 0 0 6 !1 0 0 0 0 4 !1 2 0 0 0 6 !1 4 0 0 0 4 !1 6 0 0 0 5 !1 8 0 0 0 7 ! ! !0 2 0 0 0 7 !0 4 0 0 0 5 !0 6 0 0 0 6 !0 8 0 0 0 7 !1 0 0 0 0 5 !1 2 0 0 0 7 !1 4 0 0 0 5 !1 6 0 0 0 6 !1 8 0 0 0 8 ! ! !0 2 0 0 0 8 !0 4 0 0 0 6 !0 6 0 0 0 7 !0 8 0 0 0 8 !1 0 0 0 0 6 !1 2 0 0 0 8 !1 4 0 0 0 6 !1 6 0 0 0 7 ! ! ! ! !0 4 0 0 0 7 !0 6 0 0 0 8 ! !1 0 0 0 0 7 ! !1 4 0 0 0 7 !1 6 0 0 0 8 ! ! ! ! !0 4 0 0 0 8 ! ! !1 0 0 0 0 8 ! !1 4 0 0 0 8 ! ! ! ! ! ! ! ! ! ! ! ! ! ! -------------------------------------------------------------------------------------------------------------------------- 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] Page 65 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 7 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (ANIMAL REFERENCES) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !SKIN (UNTREATED SITE) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! Focal ulcerative inflammation : due to ! ! ! ! ! ! ! ! ! ! ! mechanical irritation ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! !1 2 0 0 0 3 ! ! !1 8 0 0 0 4 ! ! moderate ! ! !0 6 0 0 0 5 !0 8 0 0 0 3 ! ! ! ! !1 8 0 0 0 5 ! ! ! ! ! !0 8 0 0 0 5 ! ! ! ! ! ! ! severe !0 2 0 0 0 6 ! ! ! ! ! ! ! !1 8 0 0 0 6 ! ! Focal epidermal erosion(s) : due to mechanical ! ! ! ! ! ! ! ! ! ! ! irritation ! ! ! ! ! ! ! ! ! ! ! slight !0 2 0 0 0 5 ! ! ! ! ! ! ! ! ! ! Focal dermal inflammatory cell infiltration : ! ! ! ! ! ! ! ! ! ! ! due to mechanical irritation ! ! ! ! ! ! ! ! ! ! ! slight !0 2 0 0 0 5 ! ! ! ! ! ! ! ! ! ! Focal epidermal hyperplasia : due to mechanical ! ! ! ! ! ! ! ! ! ! ! irritation ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! !1 2 0 0 0 3 ! ! !1 8 0 0 0 4 ! ! moderate !0 2 0 0 0 5 ! !0 6 0 0 0 5 !0 8 0 0 0 3 ! ! ! ! !1 8 0 0 0 5 ! ! !0 2 0 0 0 6 ! ! !0 8 0 0 0 5 ! ! ! ! !1 8 0 0 0 6 ! ! Focal hyperkeratosis : due to mechanical ! ! ! ! ! ! ! ! ! ! ! irritation ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! !1 2 0 0 0 3 ! ! !1 8 0 0 0 4 ! ! moderate ! ! ! !0 8 0 0 0 3 ! ! ! ! !1 8 0 0 0 5 ! ! ! ! ! ! ! ! ! ! !1 8 0 0 0 6 ! ! Focal haemorrhage : due to mechanical irritation ! ! ! ! ! ! ! ! ! ! ! slight !0 2 0 0 0 5 ! ! ! ! ! ! ! ! ! ! Focal subcutaneous inflammatory cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! ! ! !1 6 0 0 0 4 ! ! ! moderate ! ! ! ! ! !1 2 0 0 0 5 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !PITUITARY ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! Cyst(s) ! !0 4 0 0 0 6 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected !0 2 0 0 0 1 !0 4 0 0 0 1 !0 6 0 0 0 1 !0 8 0 0 0 1 !1 0 0 0 0 1 !1 2 0 0 0 1 !1 4 0 0 0 1 !1 6 0 0 0 1 !1 8 0 0 0 1 ! ! !0 2 0 0 0 2 !0 4 0 0 0 2 !0 6 0 0 0 2 !0 8 0 0 0 2 !1 0 0 0 0 2 !1 2 0 0 0 2 !1 4 0 0 0 2 !1 6 0 0 0 2 !1 8 0 0 0 2 ! ! !0 2 0 0 0 4 !0 4 0 0 0 3 !0 6 0 0 0 3 !0 8 0 0 0 3 !1 0 0 0 0 3 !1 2 0 0 0 3 !1 4 0 0 0 3 !1 6 0 0 0 3 !1 8 0 0 0 3 ! ! !0 2 0 0 0 5 !0 4 0 0 0 4 !0 6 0 0 0 4 !0 8 0 0 0 5 !1 0 0 0 0 4 !1 2 0 0 0 4 !1 4 0 0 0 4 !1 6 0 0 0 4 !1 8 0 0 0 4 ! ! ! ! ! ! ! ! ! ! ! ! -------------------------------------------------------------------------------------------------------------------------- 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] Page 66 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 8 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (ANIMAL REFERENCES) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !HEART ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! No abnormality detected !0 2 0 0 0 6 !0 4 0 0 0 5 !0 6 0 0 0 5 !0 8 0 0 0 6 !1 0 0 0 0 5 !1 2 0 0 0 5 !1 4 0 0 0 5 !1 6 0 0 0 5 !1 8 0 0 0 5 ! ! !0 2 0 0 0 7 !0 4 0 0 0 6 !0 6 0 0 0 6 !0 8 0 0 0 7 !1 0 0 0 0 6 !1 2 0 0 0 6 !1 4 0 0 0 6 !1 6 0 0 0 6 !1 8 0 0 0 6 ! ! !0 2 0 0 0 8 !0 4 0 0 0 7 !0 6 0 0 0 7 !0 8 0 0 0 8 !1 0 0 0 0 7 !1 2 0 0 0 7 !1 4 0 0 0 8 !1 6 0 0 0 7 !1 8 0 0 0 7 ! ! ! !0 4 0 0 0 8 !0 6 0 0 0 8 ! !1 0 0 0 0 8 !1 2 0 0 0 8 ! !1 6 0 0 0 8 !1 8 0 0 0 8 ! ! Focal myocardial mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight !0 2 0 0 0 3 ! ! !0 8 0 0 0 4 ! ! !1 4 0 0 0 7 ! ! ! ! ! ! ! ! ! ! ! ! ! ! !ABDOMINAL CAVITY ! ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! Focal fat necrosis ! ! !0 6 0 0 0 6 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !LIVER ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected !0 2 0 0 0 1 !0 4 0 0 0 1 !0 6 0 0 0 1 !0 8 0 0 0 1 !1 0 0 0 0 1 !1 2 0 0 0 1 !1 4 0 0 0 1 !1 6 0 0 0 1 !1 8 0 0 0 1 ! ! !0 2 0 0 0 2 !0 4 0 0 0 2 !0 6 0 0 0 2 !0 8 0 0 0 2 !1 0 0 0 0 2 !1 2 0 0 0 2 !1 4 0 0 0 3 !1 6 0 0 0 3 !1 8 0 0 0 3 ! ! !0 2 0 0 0 3 !0 4 0 0 0 3 !0 6 0 0 0 3 !0 8 0 0 0 3 !1 0 0 0 0 3 !1 2 0 0 0 3 !1 4 0 0 0 6 !1 6 0 0 0 4 !1 8 0 0 0 4 ! ! !0 2 0 0 0 4 !0 4 0 0 0 4 !0 6 0 0 0 4 !0 8 0 0 0 4 !1 0 0 0 0 4 !1 2 0 0 0 4 !1 4 0 0 0 7 !1 6 0 0 0 5 !1 8 0 0 0 5 ! ! !0 2 0 0 0 5 !0 4 0 0 0 5 !0 6 0 0 0 5 !0 8 0 0 0 5 !1 0 0 0 0 5 !1 2 0 0 0 5 ! !1 6 0 0 0 6 !1 8 0 0 0 6 ! ! !0 2 0 0 0 6 !0 4 0 0 0 6 !0 6 0 0 0 6 !0 8 0 0 0 6 !1 0 0 0 0 6 !1 2 0 0 0 6 ! !1 6 0 0 0 7 !1 8 0 0 0 7 ! ! !0 2 0 0 0 7 !0 4 0 0 0 7 !0 6 0 0 0 7 !0 8 0 0 0 7 !1 0 0 0 0 8 !1 2 0 0 0 7 ! !1 6 0 0 0 8 !1 8 0 0 0 8 ! ! !0 2 0 0 0 8 !0 4 0 0 0 8 ! !0 8 0 0 0 8 ! !1 2 0 0 0 8 ! ! ! ! ! Hepatodiaphragmatic nodule ! ! ! ! ! ! !1 4 0 0 0 4 ! !1 8 0 0 0 2 ! ! Multifocal mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! ! ! !1 6 0 0 0 2 ! ! ! Focal mononuclear cell infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! ! !0 6 0 0 0 8 ! !1 0 0 0 0 7 ! !1 4 0 0 0 2 ! ! ! ! ! ! ! ! ! ! !1 4 0 0 0 5 ! ! ! ! ! ! ! ! ! ! !1 4 0 0 0 8 ! ! ! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected !0 2 0 0 0 1 !0 4 0 0 0 1 !0 6 0 0 0 1 !0 8 0 0 0 1 !1 0 0 0 0 1 !1 2 0 0 0 1 !1 4 0 0 0 1 !1 6 0 0 0 1 !1 8 0 0 0 2 ! ! !0 2 0 0 0 3 !0 4 0 0 0 2 !0 6 0 0 0 2 !0 8 0 0 0 3 !1 0 0 0 0 2 !1 2 0 0 0 2 !1 4 0 0 0 3 !1 6 0 0 0 2 !1 8 0 0 0 3 ! ! !0 2 0 0 0 4 !0 4 0 0 0 3 !0 6 0 0 0 3 !0 8 0 0 0 4 !1 0 0 0 0 3 !1 2 0 0 0 3 !1 4 0 0 0 5 !1 6 0 0 0 3 !1 8 0 0 0 5 ! ! !0 2 0 0 0 5 !0 4 0 0 0 4 !0 6 0 0 0 4 !0 8 0 0 0 5 !1 0 0 0 0 4 !1 2 0 0 0 4 !1 4 0 0 0 6 !1 6 0 0 0 4 !1 8 0 0 0 6 ! ! !0 2 0 0 0 6 !0 4 0 0 0 5 !0 6 0 0 0 6 !0 8 0 0 0 6 !1 0 0 0 0 8 !1 2 0 0 0 5 !1 4 0 0 0 7 !1 6 0 0 0 5 ! ! ! !0 2 0 0 0 7 !0 4 0 0 0 6 !0 6 0 0 0 7 !0 8 0 0 0 7 ! !1 2 0 0 0 7 !1 4 0 0 0 8 !1 6 0 0 0 6 ! ! ! !0 2 0 0 0 8 !0 4 0 0 0 7 !0 6 0 0 0 8 ! ! !1 2 0 0 0 8 ! !1 6 0 0 0 7 ! ! ! ! !0 4 0 0 0 8 ! ! ! ! ! !1 6 0 0 0 8 ! ! ! ! ! ! ! ! ! ! ! ! ! -------------------------------------------------------------------------------------------------------------------------- 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] Page 67 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 9 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (ANIMAL REFERENCES) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !KIDNEYS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! Multifocal tubular dilatation with luminal ! ! ! ! ! ! ! ! ! ! ! hyaline substances ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! ! ! ! !1 8 0 0 0 1 ! ! U n i -l a t e r a l f o c a l t u b u l a r d i l a t a t i o n w i t h ! ! ! ! ! ! ! ! ! ! ! luminal hyaline substances ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! !0 8 0 0 0 8 !1 0 0 0 0 6 ! ! ! !1 8 0 0 0 7 ! ! ! ! ! ! ! ! ! ! !1 8 0 0 0 8 ! ! U n i -l a t e r a l f o c a l i n t e r s t i t i a l m o n o n u c l e a r c e l l ! ! ! ! ! ! ! ! ! ! ! infiltration ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! ! ! ! !1 8 0 0 0 4 ! ! moderate ! ! ! ! ! ! !1 4 0 0 0 4 ! ! ! ! U n i -l a t e r a l f o c a l c o r t i c a l s c a r ( s ) ! ! ! ! ! ! ! ! ! ! ! moderate ! ! ! ! ! ! !1 4 0 0 0 2 ! ! ! ! U n i -l a t e r a l f o c a l t u b u l a r m i n e r a l i s a t i o n ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! !0 8 0 0 0 2 ! ! ! ! ! ! ! U n i -l a t e r a l f o c a l t u b u l a r -c e l l d e g e n e r a t i o n ! ! ! ! ! ! ! ! ! ! ! very slight !0 2 0 0 0 2 ! ! ! ! ! ! ! ! ! ! Multifocal tubular basophilia ! ! ! ! ! ! ! ! ! ! ! slight ! ! !0 6 0 0 0 5 ! ! ! ! ! ! ! ! U n i -l a t e r a l m u l t i f o c a l t u b u l a r b a s o p h i l i a ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! ! ! ! ! !1 8 0 0 0 8 ! ! U n i -l a t e r a l f o c a l t u b u l a r b a s o p h i l i a ! ! ! ! ! ! ! ! ! ! ! slight ! ! ! ! !1 0 0 0 0 5 !1 2 0 0 0 6 ! ! ! ! ! ! ! ! ! !1 0 0 0 0 7 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !ADRENALS ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected !0 2 0 0 0 1 !0 4 0 0 0 1 !0 6 0 0 0 1 !0 8 0 0 0 1 !1 0 0 0 0 1 !1 2 0 0 0 1 !1 4 0 0 0 1 !1 6 0 0 0 1 !1 8 0 0 0 1 ! ! !0 2 0 0 0 2 !0 4 0 0 0 2 !0 6 0 0 0 2 !0 8 0 0 0 2 !1 0 0 0 0 2 !1 2 0 0 0 2 !1 4 0 0 0 2 !1 6 0 0 0 2 !1 8 0 0 0 2 ! ! !0 2 0 0 0 3 !0 4 0 0 0 3 !0 6 0 0 0 3 !0 8 0 0 0 3 !1 0 0 0 0 3 !1 2 0 0 0 3 !1 4 0 0 0 3 !1 6 0 0 0 3 !1 8 0 0 0 3 ! ! !0 2 0 0 0 4 !0 4 0 0 0 4 !0 6 0 0 0 4 !0 8 0 0 0 4 !1 0 0 0 0 4 !1 2 0 0 0 4 !1 4 0 0 0 4 !1 6 0 0 0 4 !1 8 0 0 0 4 ! ! !0 2 0 0 0 5 !0 4 0 0 0 5 !0 6 0 0 0 5 !0 8 0 0 0 5 !1 0 0 0 0 5 !1 2 0 0 0 5 !1 4 0 0 0 5 !1 6 0 0 0 5 !1 8 0 0 0 5 ! ! !0 2 0 0 0 6 !0 4 0 0 0 6 !0 6 0 0 0 6 !0 8 0 0 0 6 !1 0 0 0 0 6 !1 2 0 0 0 6 !1 4 0 0 0 6 !1 6 0 0 0 6 !1 8 0 0 0 6 ! ! !0 2 0 0 0 7 !0 4 0 0 0 7 !0 6 0 0 0 7 !0 8 0 0 0 7 !1 0 0 0 0 7 !1 2 0 0 0 7 !1 4 0 0 0 7 !1 6 0 0 0 7 !1 8 0 0 0 7 ! ! !0 2 0 0 0 8 !0 4 0 0 0 8 !0 6 0 0 0 8 !0 8 0 0 0 8 !1 0 0 0 0 8 !1 2 0 0 0 8 !1 4 0 0 0 8 !1 6 0 0 0 8 ! ! ! U n i -l a t e r a l a c c e s s o r y c o r t i c a l n o d u l e ( r e s t ) ! ! ! ! ! ! ! ! !1 8 0 0 0 8 ! ! ! ! ! ! ! ! ! ! ! ! -------------------------------------------------------------------------------------------------------------------------- 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] Page 68 of 68 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Dawley Rats _______________________________________________________________________________________________________________ FRAUNHOFER ITA 01G0002 Unmerged histopathological findings (all animals) Page: 10 2 1 -A u g -0 0 -------------------------------------------------------------------------------------------------------------------------- ! ! INCIDENCE OF LESIONS (ANIMAL REFERENCES) ! ! !--------------------------------------------------------------! ! ! Females ! ! -----------------------------------------------------------------------------! ! LESIONS ! T R E A T M E N T !s a l i n e !T - !T - !T - !T - !T - !T - !T - !T - ! ! ! ! !7 0 8 8 . 2 !7 3 3 8 !7 0 9 0 . 2 !7 3 3 9 !7 3 4 0 !7 3 4 1 !7 3 4 2 !7 3 4 3 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !------------------------------------------------------------------------------------------------------------------------! ! ! ! ! ! ! ! ! ! ! ! !OVARIES ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected !0 2 0 0 0 1 !0 4 0 0 0 1 !0 6 0 0 0 1 !0 8 0 0 0 1 !1 0 0 0 0 1 !1 2 0 0 0 1 !1 4 0 0 0 1 !1 6 0 0 0 1 !1 8 0 0 0 1 ! ! !0 2 0 0 0 2 !0 4 0 0 0 2 !0 6 0 0 0 2 !0 8 0 0 0 2 !1 0 0 0 0 2 !1 2 0 0 0 2 !1 4 0 0 0 2 !1 6 0 0 0 2 !1 8 0 0 0 2 ! ! !0 2 0 0 0 3 !0 4 0 0 0 3 !0 6 0 0 0 3 !0 8 0 0 0 3 !1 0 0 0 0 3 !1 2 0 0 0 3 !1 4 0 0 0 3 !1 6 0 0 0 3 !1 8 0 0 0 3 ! ! !0 2 0 0 0 4 !0 4 0 0 0 4 !0 6 0 0 0 4 !0 8 0 0 0 4 !1 0 0 0 0 4 !1 2 0 0 0 4 !1 4 0 0 0 4 !1 6 0 0 0 4 !1 8 0 0 0 4 ! ! !0 2 0 0 0 5 !0 4 0 0 0 5 !0 6 0 0 0 5 !0 8 0 0 0 5 !1 0 0 0 0 5 !1 2 0 0 0 5 !1 4 0 0 0 5 !1 6 0 0 0 5 !1 8 0 0 0 5 ! ! !0 2 0 0 0 6 !0 4 0 0 0 6 !0 6 0 0 0 6 !0 8 0 0 0 6 !1 0 0 0 0 6 !1 2 0 0 0 6 !1 4 0 0 0 6 !1 6 0 0 0 6 !1 8 0 0 0 6 ! ! !0 2 0 0 0 7 !0 4 0 0 0 7 !0 6 0 0 0 7 !0 8 0 0 0 7 !1 0 0 0 0 7 !1 2 0 0 0 7 !1 4 0 0 0 7 !1 6 0 0 0 7 !1 8 0 0 0 8 ! ! !0 2 0 0 0 8 !0 4 0 0 0 8 !0 6 0 0 0 8 !0 8 0 0 0 8 !1 0 0 0 0 8 !1 2 0 0 0 8 !1 4 0 0 0 8 !1 6 0 0 0 8 ! ! ! U n i -l a t e r a l c y s t ( s ) ! ! ! ! ! ! ! ! !1 8 0 0 0 7 ! ! Macroscopic finding: see abdominal cavity ! ! !0 6 0 0 0 6 ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !UTERUS ! ! ! ! ! ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! Dilatation ! ! ! ! ! ! ! ! ! ! ! moderate ! ! ! ! ! ! !1 4 0 0 0 1 ! ! ! ! ! ! ! ! ! ! ! ! ! ! !THYMUS ! ! ! ! ! ! ! ! ! (1) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected ! ! ! ! ! ! ! ! !1 8 0 0 0 1 ! ! ! ! ! ! ! ! ! ! ! ! !SPLEEN ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! (8) ! ! ! ! ! ! ! ! ! ! ! ! ! No abnormality detected !0 2 0 0 0 1 !0 4 0 0 0 1 !0 6 0 0 0 1 !0 8 0 0 0 1 !1 0 0 0 0 1 !1 2 0 0 0 1 !1 4 0 0 0 1 !1 6 0 0 0 1 !1 8 0 0 0 1 ! ! !0 2 0 0 0 2 !0 4 0 0 0 2 !0 6 0 0 0 2 !0 8 0 0 0 2 !1 0 0 0 0 2 !1 2 0 0 0 2 !1 4 0 0 0 2 !1 6 0 0 0 2 !1 8 0 0 0 2 ! ! !0 2 0 0 0 3 !0 4 0 0 0 3 !0 6 0 0 0 3 !0 8 0 0 0 3 !1 0 0 0 0 3 !1 2 0 0 0 3 !1 4 0 0 0 3 !1 6 0 0 0 3 !1 8 0 0 0 3 ! ! !0 2 0 0 0 4 !0 4 0 0 0 4 !0 6 0 0 0 4 !0 8 0 0 0 4 !1 0 0 0 0 4 !1 2 0 0 0 4 !1 4 0 0 0 4 !1 6 0 0 0 4 !1 8 0 0 0 4 ! ! !0 2 0 0 0 5 !0 4 0 0 0 5 !0 6 0 0 0 5 !0 8 0 0 0 5 !1 0 0 0 0 5 !1 2 0 0 0 5 !1 4 0 0 0 5 !1 6 0 0 0 5 !1 8 0 0 0 5 ! ! !0 2 0 0 0 6 !0 4 0 0 0 6 !0 6 0 0 0 6 !0 8 0 0 0 6 !1 0 0 0 0 6 !1 2 0 0 0 6 !1 4 0 0 0 6 !1 6 0 0 0 6 !1 8 0 0 0 6 ! ! !0 2 0 0 0 7 !0 4 0 0 0 7 !0 6 0 0 0 7 !0 8 0 0 0 7 !1 0 0 0 0 7 !1 2 0 0 0 7 !1 4 0 0 0 7 !1 6 0 0 0 7 !1 8 0 0 0 7 ! ! !0 2 0 0 0 8 !0 4 0 0 0 8 !0 6 0 0 0 8 !0 8 0 0 0 8 !1 0 0 0 0 8 !1 2 0 0 0 8 !1 4 0 0 0 8 !1 6 0 0 0 8 !1 8 0 0 0 8 ! ! ! ! ! ! ! ! ! ! ! ! -------------------------------------------------------------------------------------------------------------------------- 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 ***