Document Jrx2DyEY6qXYKvj05vwYyzX9a

Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 1 of 5 6 _____________________________________________________________________________________________________________ Appendix A: T es t S a m pl e R e-a na l y s is [p e r f o r m e d b y 3 M ] Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 2 of 5 6 _____________________________________________________________________________________________________________ Appendix A1: 1st T e s t S a m p l e R e -a n a l y s i s In te rn a l C o rre s p o n d e n c e 3M TO : J o h n B u te n h o ff N ovem ber 14,2000 FRO M : Fred L. DeRoos; 201-1W -29 ; 6 -06 6 5 C orp ora t e A n a l y t i c a l T ec h n ol og y C en t er REGARDING: G I D -4 2 4 2 D e t e r m i n a t i o n o f F l u o r o c h e m i c a l R e s i d u a l s i n P r o d u c t s a n d P r o d u c t T r e a te d W e b s __________________________________________________________ I n tr o d u c tio n Fou r f l u oroc h em i c a l b a sed p rodu c t s a n d p rodu c t t rea t ed w eb s w ere su b m i t t ed f or a n a l y si s t o det erm i n e t h e c on c en t ra t i on s of f l u oroc h em i c a l resi du a l s. T h e sa m p l es h a d b een p rev i ou sl y su b m i t t ed f or a n a l y si s b y M i k e M c N a m a ra u n der C A T C req u est N o. A -15 109 5 . T h e c u rren t a n a l y ses w ere c a rri ed ou t u si n g t h e sa m e m et h ods a s desc ri b ed i n t h e rep ort f or Req u est A -15 109 5 . R e s u lts T h e resu l t s f rom t h e a n a l y ses, a n d a c om p a ri son t o t h e ori g i n a l a n a l y ses, a re su m m a ri z ed i n T a b l es 1 - 6 . O n l y a n a l y t es t h a t w ere det ec t ed a re rep ort ed. T a b l e 1 . C o n c e n t r a t i o n s o f N-M e t h y l F O S E ( p p m ) S a m p l e Id e n t i f i c a t i o n 4 1 01 W P r o d u c t 4 1 01 T r e a t e d W e b N-M e t h y l F O S E N-M e t h y l F O S E (o r ig in a l) (c u r r e n t) 7 2 0p p m 7 4 0p p m 735 1 ,2 7 0 Di f f e r e n c e + 1 5 (+ 2 % ) + 5 3 0(+ 7 2 % ) F C -1 3 9 5 P r o d u c t F C -1 3 9 5 T r e a t e d W e b 9 3 0p p m ND 770 - 1 6 0 ( -1 7 % ) 180 +180 E u ro p e a n F a b ric P ro te c to r 60 ND -6 0 P ro d u ct E u ro p e a n F a b ric P ro te c to r ND ND 0 T re a te d W e b S G C a rp e t P ro te c to r P ro d u c t ND ND 0 S G C a rp e t P ro te c to r T re a te d W e b ND ND 0 Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 3 of 5 6 _____________________________________________________________________________________________________________ Memo N ov emb er 1 4 , 2 0 0 0 P a g e2 Tab l e 2 . C o n c e n t r at i o n s o f N-M e t h y l F O S A m i d e ( p p m ) S am p l e I d e n t i f i c at i o n 4 1 01 W P r o d u c t 4 1 01 T r e a t e d W e b F C -1 3 9 5 P r o d u c t F C -1 3 9 5 T r e a t e d W e b E u ro p e a n F a b ric P ro te c to r P ro d u c t E u ro p e a n F a b ric P ro te c to r T re a te d W e b S G C a rp e t P ro te c to r P ro d u c t S G C a rp e t P ro te c to r T re a te d W eb N-M e t h y l F O S A m i d e ( o r i g i n al ) ND ND 1 4 0p p m ND ND ND N-M e t h y l F O S A m id e (c u r r e n t) ND ND 1 5 0p p m ND ND ND ND ND ND ND D iffe r e n c e 0 0 + 1 0p p m (+ 7 % ) 0 0 0 0 0 Tab l e 3 . C o n c e n t r at i o n s o f N, N-D i m e t h y l F O S A m i d e ( p p m ) S am p l e I d e n t i f i c at i o n 4 1 01 W P r o d u c t 4 1 01 T r e a t e d W e b F C -1 3 9 5 P r o d u c t F C -1 3 9 5 T r e a t e d W e b E u ro p e a n F a b ric P ro te c to r P ro d u c t E u ro p e a n F a b ric P ro te c to r T re a te d W e b S G C a rp e t P ro te c to r P ro d u c t S G C a rp e t P ro te c to r T re a te d W eb N, N-D i m e t h y l F O S A m id e ( o r i g i n al ) 32 ND 7 7 0p p m ND ND ND ND ND N, N-D i m e t h y l F O S A m id e (c u r r e n t) ND ND 5 6 0p p m ND ND ND ND ND D iffe r e n c e -3 2 p p m 0 -2 1 0 p p m ( -2 7 % ) 0 0 0 0 0 Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 4 of 5 6 _____________________________________________________________________________________________________________ M em o N ovem ber 14,2000 P age 3 Table 4. Concentrations of PFOS (ppm) Sample I d entification 4 1 0 1 W P ro d u c t 4 1 0 1 T re a te d W e b F C -1 3 9 5 P r o d u c t F C -1 3 9 5 T r e a t e d W e b E u ro p e a n F a b ric P ro te c to r P ro d u c t E u ro p e a n F a b ric P ro te c to r T re a te d W e b S G C a rp e t P ro te c to r P ro d u c t S G C a rp e t P ro te c to r T re a te d W eb PFOS (orig inal) ND <5 <5 ND ND <5 220 20 0 PFOS (cu rrent) 2 11 27 <1 <1 2 610 470 D ifference ---+6 + 22 ---- ---- ---- + 3 9 0 (+ 1 8 0 % ) + 27 0 ( + 1 4 0 % ) Table 5 . Concentrations of PFH S (ppm) Sample I d entification 4 1 0 1 W P ro d u c t 4 1 0 1 T re a te d W e b F C -1 3 9 5 P r o d u c t F C -1 3 9 5 T r e a t e d W e b E u ro p e a n F a b ric P ro te c to r P ro d u c t E u ro p e a n F a b ric P ro te c to r T re a te d W e b S G C a rp e t P ro te c to r P ro d u c t S G C a rp e t P ro te c to r T re a te d W eb PFH S (orig inal) ND <5 ND ND ND <5 440 27 0 PFH S (cu rrent) 1 .2 1 .0 ND ND ND 2. 6 1 ,9 0 0 1 ,9 0 0 D ifference + 1 .2 ---- ------- ---- ---- + 1 ,5 0 0 (+ 3 4 0 % ) + 1 ,6 0 0 (+ 5 9 0 % ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 5 of 56 _____________________________________________________________________________________________________________ Memo N ov emb er 1 4 , 2 0 0 0 P a g e4 Table 6. Concentrations of FOS Amide (ppm) Sample I dentification 4 1 01 W P r o d u c t 4 1 01 T r e a t e d W e b F C -1 3 9 5 P r o d u c t F C -1 3 9 5 T r e a t e d W e b E u ro p e a n F a b ric P ro te c to r P ro d u c t E u ro p e a n F a b ric P ro te c to r T re a te d W e b S G C a rp e t P ro te c to r P ro d u c t S G C a rp e t P ro te c to r T re a te d W eb FOS Amide (orig inal) ND <5 <5 ND ND <5 ND ND FOS Amide (cu rrent) 2 .5 1 .0 110 ND ND ND 6 .0 ND D ifference ---+6 + 1 00 ---------- +6 0 Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 6 of 5 6 _____________________________________________________________________________________________________________ Appendix A2: 2nd T e s t S a m p l e R e -a n a l y s i s TO : J o h n B u te n h o ff 3M O c to b e r 2 8 , 2 0 0 3 FR O M : F r e d L . D e R o o s ; 2 0 1 -1 W -2 9 ; 6 -0 6 6 5 C A T C -C h ro m a to g ra p h y G ro u p REGARDING: Re q u e s t GID-7 8 8 8 9 , De t e r m i n a t i o n o f F l u o r o c h e m i c a l Re s i d u a l s i n P r o d u c ts a n d in T r e a te d F a b r ic In t r o d u c t i o n E ig h t s a m p le s w e re s u b m itte d fo r a n a ly s is to d e te rm in e if th e y c o n ta in e d s e m iv o la tile flu o ro c h e m ic a l re s id u a ls , s p e c ific a lly m e th y l F O S a c ry la te (M e th y l F O S E A ), m e th y l F O S m e th a c ry la te (M e th y l F O S E M A ), e th y l F O S a c ry la te (E th y l F O S E A ), e th y l F O S m e th a c ry la te (E th y l F O S E M A ), d im e th y l F O S a m id e , m e th y l F O S a m id e , e th y l F O S a m id e , d ie th y l F O S a m id e , F O S a m id e , m e th y l F O S c h lo rid e , e th y l F O S c h lo rid e , m e th y l F O S a lc o h o l o r e th y l F O S a lc o h o l. T h e s a m p le s w e re a ls o a n a ly z e d to d e te rm in e if th e y c o n ta in e d p e rflu o ro o c ty l s u lfo n ic a c id (P F O S ) o r p e rflu o ro h e x y l s u lfo n ic a c id (P F H A ). T h e s tru c tu re s o f th e flu o ro c h e m ic a l re s id u a ls o f in te re s t a re s h o w n in F ig u re 1 . T h e s p e c ific s a m p le id e n tific a tio n s a n d th e c o n c e n tra tio n s o f th e ta rg e t a n a ly te s d e te rm in e d a re lis te d in th e a tta c h e d d a ta ta b le s . T h e p ro d u c ts w e re e ith e r d ilu te d w ith a s o lv e n t b e fo re a n a ly s is o r e x tra c te d . T h e tre a te d fa b ric s w e re e x tra c te d b e fo re a n a ly s is . T h e a n a ly tic a l m e th o d s th a t w e re u s e d fo r th e s e a n a ly s e s a re d e s c rib e d in th e fo llo w in g p a ra g ra p h s . S a m p le P r e p a r a tio n T h e liq u id s a m p le s w e re d ilu te d p rio r to a n a ly s is b y m ix in g 1 g ra m o f th e s a m p le w ith 5 m L o f a c e to n itrile . T h e m ix tu re s w e re c e n trifu g e d , a n d th e n a n a liq u o t o f th e c le a r liq u id w a s tra n s fe rre d to a g la s s a u to s a m p le r v ia l. T h e w e b s a m p le s w e re e x tra c te d b y m ix in g 0 .5 g ra m s o f th e w e b w ith 5 m L o f a c e to n itrile . T h e m ix tu re s w e re s h a k e n o v e rn ig h t, a n d th e n a liq u o ts o f th e e x tra c ts w e re tra n s fe rre d to g la s s a u to s a m p le r v ia ls . An a l y t i c a l M e t h o d f o r t h e De t e r m i n a t i o n o f S e m i v o l a t i l e F l u o r o c h e m i c a l Re s i d u a l s T h e flu o ro c h e m ic a l re s id u a l c o n c e n tra tio n s w e re d e te rm in e d u s in g g a s c h ro m a to g ra p h y (H P 6 8 9 0 ) w i t h f l a m e i o n i z a t i o n d e t e c t i o n ( G C / F I D ) . A 3 0 -m e t e r D B -5 c o l u m n w i t h a 0 . 3 2 m m i n s i d e d i a m e t e r a n d a 0 . 2 5 mm f i l m t h i c k n e s s w a s u s e d f o r t h e s e p a r a t i o n s . T h e s a m p l e s w e r e i n j e c t e d s p l i t l e s s a t 5 0 oC w i t h a l i n e a r t e m p e r a t u r e r a m p o f 1 0 oC / m i n u p t o 2 7 0 oC . S t a n d a r d s o l u t i o n s o f e a c h a n a ly te w e re a n a ly z e d to p ro d u c e s ta n d a rd c u rv e s c o v e rin g th e e x p e c te d c o n c e n tra tio n ra n g e s o f th e ta rg e t a n a ly te s in th e s a m p le s (fa c to re d fo r d ilu tio n ). Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 7 of 5 6 _____________________________________________________________________________________________________________ R e p o rt O c to b e r 2 8 , 2 0 0 3 P age 2 A n a ly tic a l M e th o d fo r th e D e te r m in a tio n o f P F O S a n d P F O A R e s id u a ls T h e P F O S a n d P F O A w e re d e te rm in e d u s in g c o m b in e d h ig h p e rfo rm a n c e liq u id c h r o m a t o g r a p h y / e l e c t r o s p r a y i o n i z a t i o n m a s s s p e c t r o m e t r y ( H P L C / E S I -M S ) . T h e a n a l y s e s w e r e c a rrie d o u t u s in g a n A g ile n t M o d e l L C /M S D H P L C /M S s y s te m e q u ip p e d w ith a n d E S I s o u rc e o p e ra te d in th e n e g a tiv e io n iz a tio n m o d e . T h e s a m p le c o m p o n e n ts w e re s e p a ra te d u s in g a 1 2 5 m m x 4 m m M e r c k L i c h r o C A R T L i c h r o s p h e r e 1 0 0 R P -8 c o l u m n w i t h a m o b i l e p h a s e g r a d i e n t o f 1 0 % a c e to n itrile in w a te r to 9 5 % a c e to n itrile in w a te r o v e r a p e rio d o f 1 5 m in u te s . O CH3 C8F17 S N O CH3 D i m e t h y l FOS A m i d e C8F17 O C2H5 SN O C2H5 D i e t h y l FOS A m i d e C8F17 OH SN O CH3 M e t h y l FOS A m i d e C8F17 O CH3 SN O Cl M e t h y l FOS Ch l o r i d e C8F17 E th y l O C2H5 SN O OH FOS A l c o h o l O CH3 C8F17 S N O O O M e t h y l FOS A c r y l a t e C8F17 OH SN O C2H5 E t h y l FOS A m i d e O C8F17 S O FOS A m H N H id e C8F17 E th y l O C2H5 SN O Cl FOS Ch l o r i d e C8F17 O C2H5 SN O O O E t h y l FOS A c r y l a t e C8F17 O CH3 SN O OH M e t h y l FOS A l c o h o l O CH3 C8F17 S N O O O H3C M e t h y l FOS M e t h a c r y l a t e C8F17 O C2H5 SN O O O H3C E t h y l FOS M e t h a c r y l a t e C8F17 O S OH O P FOS C6H13 O S OH O P FHS F ig u re 1 . F lu o ro c h e m ic a l R e s id u a ls o f In te re s t Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 8 of 5 6 _____________________________________________________________________________________________________________ R e p o rt O c to b e r 2 8 , 2 0 0 3 P age 3 T h e re s u lts fro m th e a n a ly s e s a re s u m m a riz e d in T a b le 1 . T h e c o n c e n tra tio n s a re re p o rte d in u n its o f p a r t s -p e r -m i l l i o n ( p p m ) o r g / g r a m o f m a t e r i a l . Table 1. Analytical Results (parts-per-m illio n) Analyte Dimethyl FOS Amide M ethyl FOS Amide E thyl FOS Amide FOS Amide Diethyl FOS AM I DE M ethyl FOS C hlo r ide E thyl FOS C hlo r ide M ethyl FOS Alc o ho l E thyl FOS Alc o ho l M ethyl FOS Ac r yla te E thyl FOS Ac r yla te M ethyl FOS M etha c r yla te E thyl FOS M etha c r yla te P FOS P FH S T-7 0 8 8 . 2 16 160 8 .9 28 <5 13 <5 5 ,0 0 0 16 12 8 .9 20 <5 1 .0 < 0 .1 T-7 3 3 8 <10 <10 <10 <10 <10 <10 <10 1 ,6 0 0 21 <10 <10 12 <10 8 .6 0 .4 1 T-7 0 9 0 . 2 <5 7 .7 19 <5 12 <5 14 1 ,1 0 0 2 ,6 0 0 <5 18 <5 21 < 0 .5 < 0 .1 T-7 3 3 9 <10 <10 <10 <10 <10 <10 <10 <10 4 ,8 0 0 <10 <10 <10 32 <1 0 .2 4 T-7 3 4 0 430 180 <5 350 <5 140 <5 4 ,0 0 0 22 <5 200 54 38 1 .6 0 .1 4 T-7 3 4 1 <10 <10 <10 <10 <10 <10 <10 180 <10 <10 <10 <10 <10 <1 < 0 .2 T-7 3 4 2 <5 <5 <5 <5 <5 <5 <5 47 <5 <5 <5 <5 <5 180 330 T-7 3 4 3 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10 190 270 T h e d e te c tio n lim its fo r th e s e m iv o la tile flu o ro c h e m ic a l re s id u a l d e te rm in a tio n s w e re e ith e r 5 p p m o r 1 0 p p m o n a w e i g h t / w e i g h t b a s i s . S a m p l e s T -7 0 8 8 . 2 a n d T -7 3 4 0 c o n t a i n e d t h e g r e a t e s t n u m b e r o f s e p a ra te flu o ro c h e m ic a l re s id u a ls , w ith th e h ig h e s t c o n c e n tra tio n re s id u a ls b e in g m e th y l F O S a l c o h o l a n d e t h y l F O S a l c o h o l . S a m p l e T -7 3 4 3 d i d n o t c o n t a i n a n y f l u o r o c h e m i c a l r e s i d u a l s a b o v e t h e d e t e c t i o n l i m i t , w h i c h w a s 1 0 p p m f o r t h i s s a m p l e . T w o o f t h e s a m p l e s , T -7 3 4 2 a n d T -7 3 4 3 w e re fo u n d to c o n ta in s ig n ific a n t c o n c e n tra tio n s o f P F O S a n d P F H S . T h e le v e ls in th e o th e r s a m p le s w e re e ith e r lo w o r b e lo w th e d e te c tio n lim it. T h e s a m p le p re p a ra tio n s te p s a n d th e G C a n d H P L C /M S a n a ly s e s w e re c a rrie d o u t b y M ik e B u s c h , a n o n -s i t e v e n d o r e m p l o y e e . F r e d L . D e R o o s d i r e c t e d t h e w o r k , i n t e r p r e t e d t h e d a t a a n d p r e p a r e d th e fin a l re p o rt. F .L . D e R o o s Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 9 of 5 6 _____________________________________________________________________________________________________________ Appe n d i x B : Clinical Observation Data T a b le 1 : C lin ic a l S u m m a r y In c id e n c e R e p o r t 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 C l i n . O b s e r v a t i o n S u m m a r y A -E Species: Rat Sex : Both A l l s u b -s e t s Page : 1 ---------------------------------------------------------------------------------------------------------------------- Clinical Summary Incidence Report (Brief report) ---------------------------------------------------------------------------------------------------------------------- D a y s -6 - 4 2 With reference to nominal day zero Dose Group Dose Total animals A Control 16 B 1.Test art. 16 C 2.Test art. 16 D 3.Test art. 16 E 4.Test art. 16 G EN O B S WITHIN NORMAL LIMITS Incidence (%) 16(100) 16(100) 16(100) 16(100) 16(100) SKIN SCABBY SKIN Max Score 3 Incidence (%) Mean Severity TOTALS Incidence (%) 0( 0) 0.0 0( 0) 0( 0) 0.0 0( 0) 0( 0) 0.0 0( 0) 1( 6) 2.0 1( 6) 0( 0) 0.0 0( 0) 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 C l i n . O b s e r v a t i o n S u m m a r y F -I Species: Rat Sex : Both A l l s u b -s e t s Page : 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Summary Incidence Report (Brief report) ---------------------------------------------------------------------------------------------------------------------- D a y s -6 - 4 2 With reference to nominal day zero Dose Group Dose Total animals F 5.Test art. 16 G 6.Test art. 16 H 7.Test art. 16 I 8.Test art. 16 G EN O B S WITHIN NORMAL LIMITS Incidence (%) 16(100) 16(100) 16(100) 16(100) SKIN SCABBY SKIN Max Score 3 Incidence (%) Mean Severity TOTALS Incidence (%) 0( 0) 0.0 0( 0) 0( 0) 0.0 0( 0) 0( 0) 0.0 0( 0) 1( 6) 1.0 1( 6) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 1 0 of 5 6 _____________________________________________________________________________________________________________ Table 2: Individual Data on Clinical Observation 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 1 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: A Dose: Control ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 010001 GENERAL OBSERVATION WITHIN NORMAL LIMITS -6 , 0 KILLED (SCHEDULED) 4 ( 1 2 -M A Y -0 0 ) 010002 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 4 ( 1 2 -M A Y -0 0 ) 010003 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 010004 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 010005 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N -0 0 ) 010006 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N -0 0 ) 010007 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N -0 0 ) 010008 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 1 1 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 2 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: B Dose: 1.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 030001 GENERAL OBSERVATION WITHIN NORMAL LIMITS -6 , 0 KILLED (SCHEDULED) 4 ( 1 2 -M A Y -0 0 ) 030002 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 4 ( 1 2 -M A Y -0 0 ) 030003 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 030004 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 030005 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N -0 0 ) 030006 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N -0 0 ) 030007 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N -0 0 ) 030008 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 1 2 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 3 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: C Dose: 2.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 050001 GENERAL OBSERVATION WITHIN NORMAL LIMITS -6 , 0 KILLED (SCHEDULED) 4 ( 1 2 -M A Y -0 0 ) 050002 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 4 ( 1 2 -M A Y -0 0 ) 050003 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 050004 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 050005 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N -0 0 ) 050006 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N -0 0 ) 050007 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N -0 0 ) 050008 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 1 3 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 4 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: D Dose: 3.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 070001 GENERAL OBSERVATION WITHIN NORMAL LIMITS -6 , 0 KILLED (SCHEDULED) 4 ( 1 2 -M A Y -0 0 ) 070002 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 4 ( 1 2 -M A Y -0 0 ) 070003 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 070004 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 070005 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N -0 0 ) 070006 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N -0 0 ) 070007 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N -0 0 ) 070008 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 1 4 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 5 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: E Dose: 4.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 090001 GENERAL OBSERVATION WITHIN NORMAL LIMITS -6 , 0 KILLED (SCHEDULED) 4 ( 1 2 -M A Y -0 0 ) 090002 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 4 ( 1 2 -M A Y -0 0 ) 090003 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 090004 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 090005 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N -0 0 ) 090006 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N -0 0 ) 090007 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N -0 0 ) 090008 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 1 5 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 6 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: F Dose: 5.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 110001 G E NE R A L O B S E R V A T I O N W I T H I N NO R M A L L I M I T S -6 , 0 KILLED (SCHEDULED) 4 ( 1 2 -M A Y -0 0 ) 110002 G E NE R A L O B S E R V A T I O N W I T H I N NO R M A L L I M I T S KILLED (SCHEDULED) -6 , 0 4 ( 1 2 -M A Y -0 0 ) 110003 G E NE R A L O B S E R V A T I O N W I T H I N NO R M A L L I M I T S KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 110004 G E NE R A L O B S E R V A T I O N W I T H I N NO R M A L L I M I T S KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 110005 G E NE R A L O B S E R V A T I O N W I T H I N NO R M A L L I M I T S KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N-0 0 ) 110006 G E NE R A L O B S E R V A T I O N W I T H I N NO R M A L L I M I T S KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N-0 0 ) 110007 G E NE R A L O B S E R V A T I O N W I T H I N NO R M A L L I M I T S KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N-0 0 ) 110008 G E NE R A L O B S E R V A T I O N W I T H I N NO R M A L L I M I T S KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N-0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 1 6 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R ep ea t ed D er m a l Co n t a c t St u d y o f 3 M T es t A r t i c l es i n Sp r a g u e-D a w l ey R a t s F r a u n h o f er -I n s t . f . T o x i k o l o g i e u . A er o s o l f o r s c h . St u d y : 0 1 G 0 0 0 0 2 Sp ec i es : R a t Sex : Both A l l s u b -s et s Page: 7 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Cl i n i c a l Co m p r es s ed H i s t o r y R ep o r t Group: G D o s e: 6 . T es t a r t . ---------------------------------------------------------------------------------------------------------------------- A n i m a l O b s er v a t i o n Days ------- -------------------------------------------------------- --------------------------------------------------- 130001 G E N E R A L O B SE R V A T I O N WITHIN NORMAL LIMITS -6 , 0 K I L L E D ( SCH E D U L E D ) 4 ( 1 2 -M A Y -0 0 ) 130002 G E N E R A L O B SE R V A T I O N WITHIN NORMAL LIMITS K I L L E D ( SCH E D U L E D ) -6 , 0 4 ( 1 2 -M A Y -0 0 ) 130003 G E N E R A L O B SE R V A T I O N WITHIN NORMAL LIMITS K I L L E D ( SCH E D U L E D ) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 130004 G E N E R A L O B SE R V A T I O N WITHIN NORMAL LIMITS K I L L E D ( SCH E D U L E D ) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 130005 G E N E R A L O B SE R V A T I O N WITHIN NORMAL LIMITS K I L L E D ( SCH E D U L E D ) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N -0 0 ) 130006 G E N E R A L O B SE R V A T I O N WITHIN NORMAL LIMITS K I L L E D ( SCH E D U L E D ) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N -0 0 ) 130007 G E N E R A L O B SE R V A T I O N WITHIN NORMAL LIMITS K I L L E D ( SCH E D U L E D ) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N -0 0 ) 130008 G E N E R A L O B SE R V A T I O N WITHIN NORMAL LIMITS K I L L E D ( SCH E D U L E D ) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 1 7 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 8 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: H Dose: 7.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 150001 GENERAL OBSERVATION WITHIN NORMAL LIMITS -6 , 0 KILLED (SCHEDULED) 4 ( 1 2 -M A Y -0 0 ) 150002 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 4 ( 1 2 -M A Y -0 0 ) 150003 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 150004 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 150005 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N -0 0 ) 150006 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N -0 0 ) 150007 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N -0 0 ) 150008 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 1 8 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 9 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: I Dose: 8.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 170001 G E NE R A L O B S E R V A T I O N W I T H I N NO R M A L L I M I T S -6 , 0 KILLED (SCHEDULED) 4 ( 1 2 -M A Y -0 0 ) 170002 G E NE R A L O B S E R V A T I O N W I T H I N NO R M A L L I M I T S KILLED (SCHEDULED) -6 , 0 4 ( 1 2 -M A Y -0 0 ) 170003 G E NE R A L O B S E R V A T I O N W I T H I N NO R M A L L I M I T S KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 170004 G E NE R A L O B S E R V A T I O N W I T H I N NO R M A L L I M I T S KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 14 ( 2 2 -M A Y -0 0 ) 170005 G E NE R A L O B S E R V A T I O N W I T H I N NO R M A L L I M I T S KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N-0 0 ) 170006 G E NE R A L O B S E R V A T I O N W I T H I N NO R M A L L I M I T S KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 28 ( 0 5 -J U N-0 0 ) 170007 G E NE R A L O B S E R V A T I O N W I T H I N NO R M A L L I M I T S KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N-0 0 ) 170008 G E NE R A L O B S E R V A T I O N W I T H I N NO R M A L L I M I T S KILLED (SCHEDULED) -6 , 0 , 7 , 1 4 , 2 1 , 2 8 , 3 6 , 4 2 42 ( 1 9 -J U N-0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 1 9 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 10 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: A Dose: Control ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 020003 GENERAL OBSERVATION WITHIN NORMAL LIMITS -1 , 6 , 1 3 KILLED (SCHEDULED) 14 ( 2 3 -M A Y -0 0 ) 020004 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 14 ( 2 3 -M A Y -0 0 ) 020005 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 28 ( 0 6 -J U N -0 0 ) 020006 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 28 ( 0 6 -J U N -0 0 ) 020007 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 , 3 2 , 3 5 , 4 1 42 ( 2 0 -J U N -0 0 ) 020008 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 , 3 2 , 3 5 , 4 1 42 ( 2 0 -J U N -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 2 0 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 11 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: B Dose: 1.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 040003 GENERAL OBSERVATION WITHIN NORMAL LIMITS -1 , 6 , 1 3 KILLED (SCHEDULED) 14 ( 2 3 -M A Y -0 0 ) 040004 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 14 ( 2 3 -M A Y -0 0 ) 040005 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 28 ( 0 6 -J U N -0 0 ) 040006 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 28 ( 0 6 -J U N -0 0 ) 040007 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 , 3 2 , 3 5 , 4 1 42 ( 2 0 -J U N -0 0 ) 040008 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 , 3 2 , 3 5 , 4 1 42 ( 2 0 -J U N -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 2 1 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 12 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: C Dose: 2.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 060003 GENERAL OBSERVATION WITHIN NORMAL LIMITS -1 , 6 , 1 3 KILLED (SCHEDULED) 14 ( 2 3 -M A Y -0 0 ) 060004 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 14 ( 2 3 -M A Y -0 0 ) 060005 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 28 ( 0 6 -J U N -0 0 ) 060006 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 28 ( 0 6 -J U N -0 0 ) 060007 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 , 3 2 , 3 5 , 4 1 42 ( 2 0 -J U N -0 0 ) 060008 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 , 3 2 , 3 5 , 4 1 42 ( 2 0 -J U N -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 2 2 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 13 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: D Dose: 3.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 080003 GENERAL OBSERVATION WITHIN NORMAL LIMITS -1 , 6 , 1 3 KILLED (SCHEDULED) 14 ( 2 3 -M A Y -0 0 ) 080004 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 14 ( 2 3 -M A Y -0 0 ) 080005 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) SKIN SCABBY SKIN LEFT FORELEG MEDIUM B O T H -F O R E L E G MEDIUM -1 , 6 , 1 3 , 2 0 28 ( 0 6 -J U N -0 0 ) 27 28 080006 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 28 ( 0 6 -J U N -0 0 ) 080007 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 , 3 2 , 3 5 , 4 1 42 ( 2 0 -J U N -0 0 ) 080008 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 , 3 2 , 3 5 , 4 1 42 ( 2 0 -J U N -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 2 3 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 14 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: E Dose: 4.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 100003 GENERAL OBSERVATION WITHIN NORMAL LIMITS -1 , 6 , 1 3 KILLED (SCHEDULED) 14 ( 2 3 -M A Y -0 0 ) 100004 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 14 ( 2 3 -M A Y -0 0 ) 100005 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 28 ( 0 6 -J U N -0 0 ) 100006 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 28 ( 0 6 -J U N -0 0 ) 100007 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 , 3 2 , 3 5 , 4 1 42 ( 2 0 -J U N -0 0 ) 100008 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 , 3 2 , 3 5 , 4 1 42 ( 2 0 -J U N -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 2 4 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 15 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: F Dose: 5.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 120003 GENERAL OBSERVATION WITHIN NORMAL LIMITS -1 , 6 , 1 3 KILLED (SCHEDULED) 14 ( 2 3 -M A Y -0 0 ) 120004 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 14 ( 2 3 -M A Y -0 0 ) 120005 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 28 ( 0 6 -J U N -0 0 ) 120006 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 28 ( 0 6 -J U N -0 0 ) 120007 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 , 3 2 , 3 5 , 4 1 42 ( 2 0 -J U N -0 0 ) 120008 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 , 3 2 , 3 5 , 4 1 42 ( 2 0 -J U N -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 2 5 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 16 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: G Dose: 6.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 140003 GENERAL OBSERVATION WITHIN NORMAL LIMITS -1 , 6 , 1 3 KILLED (SCHEDULED) 14 ( 2 3 -M A Y -0 0 ) 140004 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 14 ( 2 3 -M A Y -0 0 ) 140005 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 28 ( 0 6 -J U N -0 0 ) 140006 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 28 ( 0 6 -J U N -0 0 ) 140007 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 , 3 2 , 3 5 , 4 1 42 ( 2 0 -J U N -0 0 ) 140008 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 , 3 2 , 3 5 , 4 1 42 ( 2 0 -J U N -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 2 6 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 17 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: H Dose: 7.Test art. --------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 160003 GENERAL OBSERVATION WITHIN NORMAL LIMITS -1 , 6 , 1 3 KILLED (SCHEDULED) 14 ( 2 3 -M A Y -0 0 ) 160004 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 14 ( 2 3 -M A Y -0 0 ) 160005 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 28 ( 0 6 -J U N -0 0 ) 160006 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 28 ( 0 6 -J U N -0 0 ) 160007 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 , 3 2 , 3 5 , 4 1 42 ( 2 0 -J U N -0 0 ) 160008 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 , 3 2 , 3 5 , 4 1 42 ( 2 0 -J U N -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 2 7 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 18 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: I Dose: 8.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 180003 GENERAL OBSERVATION WITHIN NORMAL LIMITS -1 , 6 , 1 3 KILLED (SCHEDULED) 14 ( 2 3 -M A Y -0 0 ) 180004 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 14 ( 2 3 -M A Y -0 0 ) 180005 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 28 ( 0 6 -JU N -0 0 ) 180006 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 28 ( 0 6 -JU N -0 0 ) 180007 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -1 , 6 , 1 3 , 2 0 , 3 2 , 3 5 , 4 1 42 ( 2 0 -JU N -0 0 ) 180008 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) SKIN SCABBY SKIN LEFT FORELEG SLIGHT with text -1 , 6 , 1 3 , 3 2 , 3 5 , 4 1 42 ( 2 0 -JU N -0 0 ) 20,27 Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 2 8 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R ep ea t ed D er m a l Co n t a c t St u d y o f 3 M T es t A r t i c l es i n Sp r a g u e-D a w l ey R a t s F r a u n h o f er -I n s t . f . T o x i k o l o g i e u . A er o s o l f o r s c h . St u d y : 0 1 G 0 0 0 0 2 Sp ec i es : R a t Sex : Both A l l s u b -s et s Page: 19 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Cl i n i c a l Co m p r es s ed H i s t o r y R ep o r t Group: A D o s e: Co n t r o l ---------------------------------------------------------------------------------------------------------------------- A n i m a l O b s er v a t i o n Days ------- -------------------------------------------------------- --------------------------------------------------- 020001 G E N E R A L O B SE R V A T I O N WITHIN NORMAL LIMITS -3 , 4 K I L L E D ( SCH E D U L E D ) 4 ( 1 5 -M A Y -0 0 ) 020002 G E N E R A L O B SE R V A T I O N WITHIN NORMAL LIMITS K I L L E D ( SCH E D U L E D ) -3 , 4 4 ( 1 5 -M A Y -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 2 9 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 20 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: B Dose: 1.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 040001 GENERAL OBSERVATION WITHIN NORMAL LIMITS -3 , 4 KILLED (SCHEDULED) 4 ( 1 5 -M A Y -0 0 ) 040002 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -3 , 4 4 ( 1 5 -M A Y -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 3 0 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 21 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: C Dose: 2.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 060001 GENERAL OBSERVATION WITHIN NORMAL LIMITS -3 , 4 KILLED (SCHEDULED) 4 ( 1 5 -M A Y -0 0 ) 060002 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -3 , 4 4 ( 1 5 -M A Y -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 3 1 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 22 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: D Dose: 3.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 080001 GENERAL OBSERVATION WITHIN NORMAL LIMITS -3 , 4 KILLED (SCHEDULED) 4 ( 1 5 -M A Y -0 0 ) 080002 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -3 , 4 4 ( 1 5 -M A Y -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 3 2 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 23 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: E Dose: 4.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 100001 GENERAL OBSERVATION WITHIN NORMAL LIMITS -3 , 4 KILLED (SCHEDULED) 4 ( 1 5 -M A Y -0 0 ) 100002 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -3 , 4 4 ( 1 5 -M A Y -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 3 3 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 24 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: F Dose: 5.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 120001 GENERAL OBSERVATION WITHIN NORMAL LIMITS -3 , 4 KILLED (SCHEDULED) 4 ( 1 5 -M A Y -0 0 ) 120002 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -3 , 4 4 ( 1 5 -M A Y -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 3 4 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 25 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: G Dose: 6.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 140001 GENERAL OBSERVATION WITHIN NORMAL LIMITS -3 , 4 KILLED (SCHEDULED) 4 ( 1 5 -M A Y -0 0 ) 140002 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -3 , 4 4 ( 1 5 -M A Y -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 3 5 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 26 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: H Dose: 7.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 160001 GENERAL OBSERVATION WITHIN NORMAL LIMITS -3 , 4 KILLED (SCHEDULED) 4 ( 1 5 -M A Y -0 0 ) 160002 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -3 , 4 4 ( 1 5 -M A Y -0 0 ) Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 3 6 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 27 D a y s : -6 t o 4 2 ---------------------------------------------------------------------------------------------------------------------- Clinical Compressed History Report Group: I Dose: 8.Test art. ---------------------------------------------------------------------------------------------------------------------- Animal Observation Days ------- -------------------------------------------------------- --------------------------------------------------- 180001 GENERAL OBSERVATION WITHIN NORMAL LIMITS -3 , 4 KILLED (SCHEDULED) 4 ( 1 5 -M A Y -0 0 ) 180002 GENERAL OBSERVATION WITHIN NORMAL LIMITS KILLED (SCHEDULED) -3 , 4 4 ( 1 5 -M A Y -0 0 ) *** END OF REPORT *** Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 3 7 of 5 6 _____________________________________________________________________________________________________________ Appendix C: Individual and Mean Body Weight Data 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 1 ---------------------------------------------------------------------------------------------------------------------- Body Weight [g] ---------------------------------------------------------------------------------------------------------------------- M A L E S Animal No. D a y -6 Day 0 Day 3 Day 7 Day 10 Day 14 Control A 010001 A 010002 A 010003 A 010004 A 010005 A 010006 A 010007 A 010008 264.8 262.2 248.2 259.9 263.2 256.3 258.0 270.1 294.1 289.3 278.2 280.0 288.2 281.1 280.3 297.4 293.6 294.0 275.7 282.9 285.3 281.5 268.3 300.6 278.2 289.6 296.1 296.6 269.0 310.1 280.8 304.6 303.7 304.0 278.7 321.1 289.0 311.7 304.4 311.8 287.7 328.6 Control Mean 260.3 SD 6.5 n 8 286.1 7.2 8 285.2 10.6 8 289.9 14.6 6 298.8 16.2 6 305.5 15.5 6 1.Test art. B 030001 B 030002 B 030003 B 030004 B 030005 B 030006 B 030007 B 030008 259.3 255.1 260.8 261.9 259.6 238.9 253.9 258.1 285.1 284.4 284.7 280.2 291.1 255.0 278.2 280.4 290.6 285.3 276.0 287.2 292.5 264.2 280.1 279.1 282.3 295.2 302.3 267.9 289.4 285.8 294.2 296.6 307.0 274.7 291.9 288.1 300.5 306.9 317.4 280.4 300.0 300.0 1.Test art. Mean 256.0 SD 7.4 n 8 279.9 10.8 8 281.9 9.2 8 287.2 11.8 6 292.1 10.6 6 300.9 12.1 6 2.Test art. C 050001 C 050002 C 050003 C 050004 C 050005 C 050006 C 050007 C 050008 257.8 249.7 254.3 253.9 272.5 242.4 253.1 268.9 277.5 276.6 279.8 277.9 301.7 261.6 271.7 297.3 282.3 279.8 262.2 274.1 309.1 265.0 274.7 298.9 274.4 283.4 321.5 274.0 279.6 308.3 283.2 289.4 328.7 283.6 291.1 319.9 309.7 293.1 313.5 293.0 303.3 334.9 2.Test art. Mean 256.6 SD 9.9 n 8 280.5 13.1 8 280.8 16.1 8 290.2 19.9 6 299.3 19.8 6 307.9 15.7 6 3.Test art. D 070001 D 070002 D 070003 D 070004 D 070005 D 070006 D 070007 D 070008 260.6 268.5 258.4 267.1 266.5 248.5 253.3 261.5 285.9 300.4 277.1 268.9 292.3 274.3 275.7 292.1 283.7 307.9 271.0 273.0 290.1 278.3 275.9 294.2 273.5 280.3 298.1 290.2 284.7 301.3 283.7 290.2 301.0 293.7 288.7 307.9 289.1 298.8 315.1 306.9 300.2 313.5 3.Test art. Mean 260.6 SD 7.0 n 8 283.3 11.0 8 284.3 12.5 8 288.0 10.6 6 294.2 8.8 6 303.9 9.9 6 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 3 8 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 2 ---------------------------------------------------------------------------------------------------------------------- Body Weight [g] ---------------------------------------------------------------------------------------------------------------------- M A L E S Animal No. D a y -6 Day 0 Day 3 Day 7 Day 10 Day 14 4.Test art. E 090001 E 090002 E 090003 E 090004 E 090005 E 090006 E 090007 E 090008 265.8 262.0 246.2 256.0 262.4 245.1 249.4 265.1 293.3 289.3 264.5 286.3 288.6 272.8 274.6 306.7 288.6 297.0 264.9 282.5 299.7 278.8 285.3 313.2 275.0 287.9 302.8 289.4 291.9 328.6 279.5 295.6 312.6 294.6 301.3 337.7 281.8 297.3 318.8 306.2 317.2 354.2 4.Test art. Mean 256.5 SD 8.6 n 8 284.5 13.4 8 288.8 14.7 8 295.9 18.3 6 303.6 19.9 6 312.6 24.6 6 5.Test art. F 110001 F 110002 F 110003 F 110004 F 110005 F 110006 F 110007 F 110008 266.9 258.2 239.1 244.3 270.1 240.9 249.0 264.6 296.0 283.8 250.0 267.3 302.0 268.6 278.7 295.2 302.8 290.3 247.6 267.3 296.9 273.4 279.1 292.7 245.6 272.4 308.1 287.5 284.9 306.1 253.0 280.5 316.5 293.8 295.1 317.0 256.9 295.0 326.6 291.8 300.4 325.2 5.Test art. Mean 254.1 SD 12.4 n 8 280.2 17.6 8 281.3 18.2 8 284.1 23.2 6 292.7 24.0 6 299.3 25.7 6 6.Test art. G 130001 G 130002 G 130003 G 130004 G 130005 255.4 262.7 249.5 255.2 261.7 288.8 297.8 284.2 284.7 293.6 289.7 303.9 288.2 294.9 298.8 297.1 302.6 309.8 303.1 307.7 319.9 316.2 313.5 323.5 G 130006 G 130007 G 130008 233.9 251.9 268.3 256.8 281.9 297.4 258.8 284.2 300.2 267.5 295.0 313.6 275.5 295.8 319.4 277.2 309.5 337.4 6.Test art. Mean 254.8 SD 10.5 n 8 285.7 13.1 8 289.8 14.2 8 297.6 16.4 6 303.6 16.6 6 312.9 20.0 6 7.Test art. H 150001 H 150002 H 150003 H 150004 H 150005 H 150006 H 150007 H 150008 259.3 260.4 252.0 254.4 261.4 243.2 242.2 261.0 278.9 280.4 279.2 284.2 284.7 273.8 262.5 284.5 288.6 273.6 287.9 276.9 288.9 280.8 267.0 288.1 299.9 282.0 297.3 293.2 272.5 294.4 304.2 282.1 303.9 298.8 274.7 296.0 308.7 302.7 314.3 314.3 283.1 306.0 7.Test art. Mean 254.2 SD 7.9 n 8 278.5 7.5 8 281.5 8.3 8 289.9 10.5 6 293.3 12.2 6 304.9 11.6 6 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 3 9 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 3 ---------------------------------------------------------------------------------------------------------------------- Body Weight [g] ---------------------------------------------------------------------------------------------------------------------- M A L E S Animal No. D a y -6 Day 0 Day 3 Day 7 Day 10 Day 14 8.Test art. I 170001 I 170002 I 170003 I 170004 I 170005 I 170006 I 170007 I 170008 262.9 251.5 259.4 245.8 257.2 249.4 255.0 268.1 296.5 280.1 291.7 272.4 281.9 269.7 283.3 300.3 300.6 284.6 285.4 281.7 280.3 268.7 285.7 308.2 296.7 295.1 291.2 275.5 300.5 318.7 301.4 304.7 298.5 279.8 302.7 331.3 315.6 311.2 301.4 296.8 318.5 344.8 8.Test art. Mean 256.2 SD 7.3 n 8 284.5 10.9 8 286.9 12.3 8 296.3 14.0 6 303.1 16.5 6 314.7 16.9 6 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 4 0 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 4 ---------------------------------------------------------------------------------------------------------------------- Body Weight [g] ---------------------------------------------------------------------------------------------------------------------- F E M A L E S Animal No. D a y -6 Day 0 Day 3 Day 7 Day 10 Day 14 Control A 020003 A 020004 A 020005 A 020006 A 020007 A 020008 A 020001 A 020002 199.3 203.7 195.8 196.9 198.8 209.3 189.7 212.6 209.5 208.9 205.4 220.6 201.5 213.3 194.3 205.2 226.1 214.9 212.6 214.7 202.8 217.1 198.7 214.6 236.8 221.2 215.0 226.0 210.2 224.5 246.4 229.2 217.7 227.6 214.1 230.7 264.0 236.5 224.3 234.2 216.9 238.2 Control Mean 200.8 SD 7.5 n 8 207.3 7.8 8 212.7 8.5 8 222.3 9.3 6 227.6 11.4 6 235.7 16.1 6 1.Test art. B 040003 B 040004 B 040005 B 040006 B 040007 B 040008 B 040001 B 040002 202.2 213.3 196.6 191.4 192.1 208.2 185.5 207.4 231.1 210.7 209.1 198.9 213.6 217.8 194.1 206.1 233.1 211.6 216.1 207.0 210.6 219.9 213.1 221.0 232.3 220.3 222.8 209.2 214.0 228.3 237.6 223.6 228.9 217.9 205.8 236.3 247.3 235.1 234.1 220.9 216.7 247.6 1.Test art. Mean 199.6 SD 9.7 n 8 210.2 11.4 8 216.6 8.2 8 221.2 8.6 6 225.0 12.0 6 233.6 12.9 6 2.Test art. C 060003 C 060004 C 060005 C 060006 C 060007 C 060008 C 060001 C 060002 201.0 203.5 189.2 201.6 195.6 206.4 180.8 218.9 208.0 218.6 199.0 212.6 202.3 211.6 202.1 223.1 215.1 224.5 197.0 218.6 203.3 214.6 192.3 219.2 219.0 232.3 204.4 230.2 211.7 224.5 221.2 236.4 207.9 238.3 227.1 226.7 233.3 241.5 212.0 243.7 229.2 235.5 2.Test art. Mean 199.6 SD 11.4 n 8 209.7 8.5 8 210.6 11.6 8 220.4 10.8 6 226.3 11.1 6 232.5 11.4 6 3.Test art. D 080003 D 080004 D 080005 D 080006 D 080007 D 080008 D 080001 D 080002 199.7 196.0 203.2 204.3 187.6 186.7 183.8 209.0 205.3 206.8 215.0 216.3 202.1 202.9 196.1 231.4 210.6 211.5 219.9 219.7 205.6 201.6 205.6 229.2 226.1 229.0 223.3 229.9 217.9 217.4 236.7 241.8 248.0 232.3 214.3 230.2 242.0 243.4 253.1 250.5 224.3 227.4 3.Test art. Mean 196.3 SD 9.3 n 8 209.5 11.1 8 213.0 9.3 8 223.9 5.4 6 233.9 11.6 6 240.1 11.9 6 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 4 1 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e rm a l C o n t a c t S t u d y o f 3 M T e s t A rt i c l e s i n S p ra g u e -D a w l e y R a t s F ra u n h o f e r-I n s t . f . T o x i k o l o g i e u . A e ro s o l f o rs c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 5 ---------------------------------------------------------------------------------------------------------------------- Body Weight [g] ---------------------------------------------------------------------------------------------------------------------- F E M A L E S Animal No. D a y -6 Day 0 Day 3 Day 7 Day 10 Day 14 4 . T e s t a rt . E 100003 E 100004 E 100005 E 100006 E 100007 E 100008 E 100001 E 100002 204.5 210.1 189.2 198.8 186.6 204.4 194.8 203.7 206.1 224.4 198.8 202.6 196.3 226.0 209.3 203.1 211.7 230.3 201.0 202.8 198.1 229.5 203.9 216.2 220.9 235.4 209.3 206.9 210.1 238.6 226.0 239.2 203.5 211.7 208.2 238.4 231.3 243.4 219.1 220.1 216.1 253.5 4 . T e s t a rt . Mean 199.0 SD 8.2 n 8 208.3 11.2 8 211.7 12.7 8 220.2 13.9 6 221.2 15.6 6 230.6 15.1 6 5 . T e s t a rt . F 120003 F 120004 F 120005 F 120006 F 120007 F 120008 F 120001 F 120002 208.7 199.0 201.4 201.3 189.5 194.7 191.6 202.9 216.7 203.9 205.1 217.6 204.9 209.3 201.6 224.7 215.2 207.5 209.0 216.8 205.6 217.6 205.1 229.7 237.4 222.2 216.1 225.5 212.1 231.1 248.0 225.2 222.3 234.2 220.9 228.5 251.4 227.4 238.0 236.7 227.8 240.3 5 . T e s t a rt . Mean 198.6 SD 6.4 n 8 210.5 8.2 8 213.3 8.3 8 224.1 9.4 6 229.9 10.1 6 236.9 8.9 6 6 . T e s t a rt . G 140003 G 140004 G 140005 G 140006 G 140007 G 140008 G 140001 G 140002 211.9 205.8 198.9 217.6 185.4 204.7 204.2 209.1 207.1 208.1 204.6 218.6 184.6 205.3 211.6 222.3 217.6 206.3 205.7 219.4 191.3 216.9 222.2 229.2 223.2 222.2 214.6 229.3 205.9 227.9 220.3 217.1 221.9 226.6 204.7 227.5 226.8 222.8 229.3 233.3 209.7 235.5 6 . T e s t a rt . Mean 204.7 SD 9.6 n 8 207.8 11.3 8 213.6 11.9 8 220.5 8.8 6 219.7 8.3 6 226.2 9.3 6 7 . T e s t a rt . H 160003 H 160004 H 160005 H 160006 H 160007 H 160008 H 160001 H 160002 203.7 191.4 202.0 199.4 187.0 207.6 196.2 205.8 209.6 200.8 208.6 199.8 191.4 206.2 213.6 208.9 216.4 206.2 207.5 213.1 195.5 201.7 211.1 216.4 230.9 212.7 226.1 222.2 205.1 212.1 227.5 210.7 229.8 222.0 206.6 213.4 240.8 217.4 234.5 231.7 211.3 221.5 7 . T e s t a rt . Mean 199.1 SD 7.2 n 8 204.9 7.1 8 208.5 7.3 8 218.2 9.8 6 218.3 9.5 6 226.2 11.3 6 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 4 2 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 6 ---------------------------------------------------------------------------------------------------------------------- Body Weight [g] ---------------------------------------------------------------------------------------------------------------------- F E M A L E S Animal No. D a y -6 Day 0 Day 3 Day 7 Day 10 Day 14 8.Test art. I 180003 I 180004 I 180005 I 180006 I 180007 I 180008 I 180001 I 180002 192.9 203.1 197.2 199.0 193.6 212.0 194.3 213.2 200.3 212.6 203.4 208.7 202.3 240.4 207.1 229.0 211.2 212.9 206.5 215.3 205.2 241.6 204.4 235.7 225.8 223.5 210.3 228.2 216.7 251.4 219.9 229.3 219.2 233.8 215.2 252.2 225.4 236.8 222.0 234.2 233.6 266.5 8.Test art. Mean 200.7 SD 8.1 n 8 213.0 14.3 8 216.6 14.2 8 226.0 14.1 6 228.3 13.6 6 236.4 15.8 6 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 4 3 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 7 ---------------------------------------------------------------------------------------------------------------------- Body Weight [g] ---------------------------------------------------------------------------------------------------------------------- M A L E S Animal No. Day 17 Day 21 Day 24 Day 28 Day 31 Day 35 Control Control 1.Test art. 1.Test art. 2.Test art. 2.Test art. A 010005 A 010006 A 010007 A 010008 Mean SD n B 030005 B 030006 B 030007 B 030008 Mean SD n C 050005 C 050006 C 050007 C 050008 Mean SD n 310.6 329.4 285.9 334.8 315.2 22.1 4 318.2 280.9 304.8 305.8 302.4 15.6 4 333.0 300.4 305.6 340.0 319.8 19.7 4 316.2 329.1 297.5 343.5 321.6 19.5 4 323.5 276.5 312.1 332.4 311.1 24.5 4 340.3 304.3 309.8 343.7 324.5 20.4 4 323.0 326.7 287.5 344.3 320.4 23.8 4 325.2 279.8 318.6 318.9 310.6 20.8 4 356.9 311.5 315.1 347.2 332.7 22.8 4 324.9 338.3 294.2 354.7 328.0 25.6 4 337.1 288.0 326.8 327.0 319.7 21.7 4 367.4 314.6 329.5 354.2 341.4 23.8 4 315.2 365.9 340.6 35.9 2 338.2 325.9 332.1 8.7 2 338.2 369.8 354.0 22.3 2 320.8 365.4 343.1 31.5 2 337.7 342.0 339.9 3.0 2 346.4 378.1 362.3 22.4 2 3.Test art. D 070005 D 070006 D 070007 D 070008 320.1 311.3 302.6 322.4 322.5 314.9 314.4 326.5 321.5 315.6 316.8 326.9 332.1 328.9 329.3 336.2 343.7 350.1 348.5 352.1 3.Test art. Mean 314.1 SD 9.0 n 4 319.6 5.9 4 320.2 5.1 4 331.6 3.4 4 346.9 4.5 2 350.3 2.5 2 4.Test art. E 090005 E 090006 E 090007 E 090008 328.8 318.8 323.5 358.6 329.4 318.9 323.8 362.1 333.5 315.3 329.8 367.6 336.4 329.1 338.8 378.0 356.7 394.6 360.3 402.0 4.Test art. Mean 332.4 SD 17.9 n 4 333.6 19.5 4 336.6 22.1 4 345.6 22.0 4 375.7 26.8 2 381.2 29.5 2 5.Test art. F 110005 F 110006 F 110007 F 110008 322.9 306.3 308.0 333.4 336.0 310.2 310.2 343.1 329.4 315.9 315.4 347.7 339.5 328.0 322.3 355.8 336.6 367.0 347.4 376.6 5.Test art. Mean 317.7 SD 12.9 n 4 324.9 17.2 4 327.1 15.2 4 336.4 14.8 4 351.8 21.5 2 362.0 20.6 2 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 4 4 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 8 ---------------------------------------------------------------------------------------------------------------------- Body Weight [g] ---------------------------------------------------------------------------------------------------------------------- M A L E S Animal No. Day 17 Day 21 Day 24 Day 28 Day 31 Day 35 6.Test art. G 130005 G 130006 G 130007 G 130008 327.2 282.7 308.8 344.7 338.7 284.9 315.3 346.1 329.9 290.8 313.7 346.9 341.9 298.2 324.1 355.3 333.7 368.6 334.8 374.8 6.Test art. Mean 315.9 SD 26.5 n 4 321.3 27.6 4 320.3 23.9 4 329.9 24.7 4 351.2 24.7 2 354.8 28.3 2 7.Test art. H 150005 H 150006 H 150007 H 150008 311.3 318.2 283.5 303.0 311.9 322.5 286.0 309.2 316.7 325.5 293.0 311.7 323.9 330.9 301.6 325.3 310.4 338.4 314.6 338.1 7.Test art. Mean 304.0 SD 15.0 n 4 307.4 15.4 4 311.7 13.7 4 320.4 12.9 4 324.4 19.8 2 326.4 16.6 2 8.Test art. I 170005 I 170006 I 170007 I 170008 303.0 292.4 316.9 336.7 307.8 305.7 320.1 346.7 313.6 311.6 327.9 345.1 328.3 320.1 334.9 361.4 346.5 374.0 359.4 382.3 8.Test art. Mean 312.3 SD 19.1 n 4 320.1 18.9 4 324.6 15.5 4 336.2 17.9 4 360.3 19.4 2 370.9 16.2 2 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 4 5 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 9 ---------------------------------------------------------------------------------------------------------------------- Body Weight [g] ---------------------------------------------------------------------------------------------------------------------- F E M A L E S Animal No. Day 17 Day 21 Day 24 Day 28 Day 31 Day 35 Control Control 1.Test art. 1.Test art. 2.Test art. 2.Test art. A 020005 A 020006 A 020007 A 020008 Mean SD n B 040005 B 040006 B 040007 B 040008 Mean SD n C 060005 C 060006 C 060007 C 060008 Mean SD n 228.1 243.4 219.2 237.0 231.9 10.6 4 238.6 222.5 217.7 255.9 233.7 17.3 4 211.1 240.9 238.3 237.7 232.0 14.0 4 228.8 250.2 220.8 236.3 234.0 12.5 4 234.0 232.3 227.3 247.9 235.4 8.8 4 219.9 250.7 228.9 239.2 234.7 13.3 4 230.4 254.0 224.0 243.3 237.9 13.4 4 241.9 226.6 221.0 247.1 234.2 12.4 4 230.9 242.0 236.5 241.7 237.8 5.2 4 232.9 259.1 224.3 248.8 241.3 15.6 4 250.2 234.6 228.8 257.7 242.8 13.4 4 232.7 247.6 246.0 252.2 244.6 8.4 4 229.0 252.4 240.7 16.5 2 236.9 267.0 252.0 21.3 2 248.0 258.4 253.2 7.4 2 231.2 262.0 246.6 21.8 2 237.8 269.2 253.5 22.2 2 246.2 256.4 251.3 7.2 2 3.Test art. D 080005 D 080006 D 080007 D 080008 250.4 245.5 223.4 228.5 262.0 249.8 232.2 237.4 265.2 245.8 227.6 231.7 271.8 253.8 232.5 242.5 240.3 261.1 240.7 269.8 3.Test art. Mean 237.0 SD 13.0 n 4 245.4 13.3 4 242.6 17.0 4 250.2 16.9 4 250.7 14.7 2 255.3 20.6 2 4.Test art. E 100005 E 100006 E 100007 E 100008 224.0 218.0 221.4 254.8 233.5 214.3 227.6 260.6 230.6 214.0 229.8 262.6 234.9 218.9 233.4 270.7 237.0 277.2 244.2 278.6 4.Test art. Mean 229.6 SD 17.0 n 4 234.0 19.5 4 234.3 20.4 4 239.5 22.0 4 257.1 28.4 2 261.4 24.3 2 5.Test art. F 120005 F 120006 F 120007 F 120008 241.7 242.8 230.9 238.2 239.9 249.1 239.7 247.9 250.5 256.6 238.2 247.3 254.2 254.8 244.4 252.8 246.4 254.4 250.4 260.7 5.Test art. Mean 238.4 SD 5.4 n 4 244.2 5.0 4 248.2 7.7 4 251.6 4.8 4 250.4 5.7 2 255.6 7.3 2 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 4 6 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 10 ---------------------------------------------------------------------------------------------------------------------- Body Weight [g] ---------------------------------------------------------------------------------------------------------------------- F E M A L E S Animal No. Day 17 Day 21 Day 24 Day 28 Day 31 Day 35 6.Test art. G 140005 G 140006 G 140007 G 140008 231.2 238.0 216.8 236.4 237.2 247.1 228.7 249.3 242.8 240.3 224.5 244.8 244.0 251.1 231.9 253.5 239.8 250.8 240.3 249.3 6.Test art. Mean 230.6 SD 9.6 n 4 240.6 9.5 4 238.1 9.3 4 245.1 9.7 4 245.3 7.8 2 244.8 6.4 2 7.Test art. H 160005 H 160006 H 160007 H 160008 239.3 234.0 211.7 224.3 249.7 241.9 235.7 237.8 254.3 241.3 218.6 236.5 257.4 246.1 221.5 241.4 222.4 249.3 229.7 258.5 7.Test art. Mean 227.3 SD 12.1 n 4 241.3 6.2 4 237.7 14.8 4 241.6 15.0 4 235.9 19.0 2 244.1 20.4 2 8.Test art. I 180005 I 180006 I 180007 I 180008 225.1 239.2 232.9 265.6 230.2 243.9 237.9 269.4 236.4 241.5 241.5 274.9 238.6 254.5 247.7 281.7 249.7 288.2 255.2 288.2 8.Test art. Mean 240.7 SD 17.6 n 4 245.4 17.0 4 248.6 17.7 4 255.6 18.6 4 269.0 27.2 2 271.7 23.3 2 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 4 7 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 11 ---------------------------------------------------------------------------------------------------------------------- Body Weight [g] ---------------------------------------------------------------------------------------------------------------------- M A L E S Animal No. Day 38 Day 42 Control A 010007 A 010008 324.1 374.8 336.7 378.0 Control Mean 349.5 SD 35.8 n 2 357.4 29.2 2 1.Test art. B 030007 B 030008 348.5 347.6 352.3 357.2 1.Test art. Mean 348.1 SD 0.6 n 2 354.8 3.5 2 2.Test art. C 050007 C 050008 354.8 383.0 361.0 390.4 2.Test art. Mean 368.9 SD 19.9 n 2 375.7 20.8 2 3.Test art. D 070007 D 070008 358.0 371.0 363.7 383.6 3.Test art. Mean 364.5 SD 9.2 n 2 373.7 14.1 2 4.Test art. E 090007 E 090008 362.1 407.3 374.2 412.9 4.Test art. Mean 384.7 SD 32.0 n 2 393.6 27.4 2 5.Test art. F 110007 F 110008 356.9 377.1 368.1 384.1 5.Test art. Mean 367.0 SD 14.3 n 2 376.1 11.3 2 6.Test art. G 130007 G 130008 338.9 377.8 348.4 385.2 6.Test art. Mean 358.4 SD 27.5 n 2 366.8 26.0 2 7.Test art. H 150007 H 150008 320.8 343.5 330.0 347.4 7.Test art. Mean 332.2 SD 16.1 n 2 338.7 12.3 2 8.Test art. I 170007 I 170008 365.1 389.7 375.2 399.5 8.Test art. Mean 377.4 SD 17.4 n 2 387.4 17.2 2 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 4 8 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 12 ---------------------------------------------------------------------------------------------------------------------- Body Weight [g] --------------------------------------------------------------------------------------------------------------------- F E M A L E S Animal No. Day 38 Day 42 Control A 020007 A 020008 232.6 261.6 233.6 258.1 Control Mean 247.1 SD 20.5 n 2 245.9 17.3 2 1.Test art. B 040007 B 040008 234.2 269.7 243.0 271.2 1.Test art. Mean 252.0 SD 25.1 n 2 257.1 19.9 2 2.Test art. C 060007 C 060008 245.5 259.5 248.1 260.8 2.Test art. Mean 252.5 SD 9.9 n 2 254.5 9.0 2 3.Test art. D 080007 D 080008 237.9 256.6 245.5 256.4 3.Test art. Mean 247.3 SD 13.2 n 2 251.0 7.7 2 4.Test art. E 100007 E 100008 251.1 279.7 250.6 281.0 4.Test art. Mean 265.4 SD 20.2 n 2 265.8 21.5 2 5.Test art. F 120007 F 120008 254.8 259.9 261.9 260.7 5.Test art. Mean 257.4 SD 3.6 n 2 261.3 0.8 2 6.Test art. G 140007 G 140008 244.5 261.4 245.4 260.2 6.Test art. Mean 253.0 SD 12.0 n 2 252.8 10.5 2 7.Test art. H 160007 H 160008 224.8 257.3 217.6 254.5 7.Test art. Mean 241.1 SD 23.0 n 2 236.1 26.1 2 8.Test art. I 180007 I 180008 246.0 290.6 259.8 298.6 8.Test art. Mean 268.3 SD 31.5 n 2 279.2 27.4 2 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal *** END OF REPORT *** Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 4 9 of 5 6 _____________________________________________________________________________________________________________ Appendix D: Absolute and Relative Liver Weights 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t St u d y o f 3 M T e s t A r t i c l e s i n Sp r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . St u d y : 0 1 G 0 0 0 0 2 Sp e c i e s : R a t Se x : Both A l l s u b -s e t s Page : 1 ---------------------------------------------------------------------------------------------------------------------- Terminal Body Weight & Liver Weight Data ---------------------------------------------------------------------------------------------------------------------- M A L E S Animal No. Day 4 TermBW G Day 4 Liver Day 4 r.Liver g/kg Day 14 TermBW G Day 14 Liver Day 14 r.Liver g/kg Control A 010001 A 010002 A 010003 A 010004 295.7 289.1 12.147 12.155 41.08 42.04 289.1 309.7 11.154 11.934 38.58 38.53 Control Mean 292.4 SD 4.7 n 2 12.151 0.000 2 41.56 0.68 2 299.4 14.6 2 11.544 0.551 2 38.56 0.03 2 1.Test art. B 030001 B 030002 B 030003 B 030004 281.4 283.0 11.519 11.274 40.93 39.84 298.3 304.3 11.447 11.668 38.37 38.34 1.Test art. Mean 282.2 SD 1.1 n 2 11.396 0.173 2 40.39 0.77 2 301.3 4.2 2 11.557 0.156 2 38.36 0.02 2 2.Test art. C 050001 C 050002 C 050003 C 050004 276.9 267.5 12.534 10.301 45.26 38.51 300.8 289.9 13.970 10.641 46.44 36.71 2.Test art. Mean 272.2 SD 6.6 n 2 11.417 1.578 2 41.89 4.78 2 295.4 7.7 2 12.305 2.354 2 41.57 6.89 2 3.Test art. D 070001 D 070002 D 070003 D 070004 285.5 305.4 12.997 12.392 45.52 40.57 288.7 295.7 10.214 12.236 35.38 41.38 3.Test art. Mean 295.5 SD 14.1 n 2 12.694 0.428 2 43.05 3.50 2 292.2 5.0 2 11.225 1.430 2 38.38 4.25 2 4.Test art. E 090001 E 090002 E 090003 E 090004 281.1 290.4 11.495 12.497 40.89 43.03 281.7 299.0 11.052 11.313 39.23 37.84 4.Test art. Mean 285.8 SD 6.6 n 2 11.996 0.708 2 41.96 1.51 2 290.4 12.2 2 11.182 0.185 2 38.53 0.99 2 5.Test art. F 110001 F 110002 F 110003 F 110004 296.8 294.9 13.038 12.458 43.93 42.24 255.7 294.4 9.788 11.666 38.28 39.63 5.Test art. Mean 295.9 SD 1.3 n 2 12.748 0.411 2 43.09 1.19 2 275.1 27.4 2 10.727 1.328 2 38.95 0.95 2 ---------------------------------------------------------------------------------------------------------------------- St a t i s t i c s : A n o v a + D u n n e t t ' s t e s t s . ( T w o -Si d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 5 0 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 2 ---------------------------------------------------------------------------------------------------------------------- Terminal Body Weight & Liver Weight Data ---------------------------------------------------------------------------------------------------------------------- M A L E S Animal No. Day 4 TermBW G Day 4 Liver Day 4 r.Liver g/kg Day 14 TermBW G Day 14 Liver Day 14 r.Liver g/kg 6.Test art. G 130001 G 130002 G 130003 G 130004 285.0 305.5 11.965 13.261 41.98 43.41 310.8 311.0 11.860 13.058 38.16 41.99 6.Test art. Mean 295.3 SD 14.5 n 2 12.613 0.916 2 42.69 1.01 2 310.9 0.2 2 12.459 0.847 2 40.07 2.71 2 7.Test art. H 150001 H 150002 H 150003 H 150004 282.6 270.1 11.841 10.673 41.90 39.52 311.2 291.9 12.534 12.780 40.28 43.78 7.Test art. Mean 276.4 SD 8.8 n 2 11.257 0.826 2 40.71 1.69 2 301.6 13.6 2 12.657 0.173 2 42.03 2.48 2 8.Test art. I 170001 I 170002 I 170003 I 170004 294.3 282.1 11.339 12.552 38.53 44.50 312.5 309.6 12.312 12.403 39.40 40.06 8.Test art. Mean 288.2 SD 8.6 n 2 11.946 0.858 2 41.51 4.22 2 311.1 2.0 2 12.358 0.064 2 39.73 0.47 2 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 5 1 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 3 ---------------------------------------------------------------------------------------------------------------------- Terminal Body Weight & Liver Weight Data ---------------------------------------------------------------------------------------------------------------------- F E M A L E S Animal No. Day 4 TermBW G Day 4 Liver Day 4 r.Liver g/kg Day 14 TermBW G Day 14 Liver Day 14 r.Liver g/kg Control A 020003 A 020004 A 020001 A 020002 194.2 218.2 6.873 8.125 35.39 37.24 259.9 237.1 9.740 9.491 37.47 40.03 Control Mean 206.2 SD 17.0 n 2 7.499 0.885 2 36.31 1.30 2 248.5 16.1 2 9.615 0.176 2 38.75 1.81 2 1.Test art. B 040003 B 040004 B 040001 B 040002 213.0 216.1 8.556 8.339 40.17 38.59 242.6 231.1 9.870 9.950 40.68 43.05 1.Test art. Mean 214.6 SD 2.2 n 2 8.447 0.153 2 39.38 1.12 2 236.9 8.1 2 9.910 0.056 2 41.87 1.67 2 2.Test art. C 060003 C 060004 C 060001 C 060002 187.2 219.3 6.521 9.212 34.84 42.01 229.3 239.5 10.304 10.648 44.94 44.46 2.Test art. Mean 203.3 SD 22.7 n 2 7.867 1.903 2 38.42 5.07 2 234.4 7.2 2 10.476 0.243 2 44.70 0.34 2 3.Test art. D 080003 D 080004 D 080001 D 080002 206.2 228.2 7.878 9.416 38.21 41.26 237.4 244.1 10.911 10.452 45.96 42.82 3.Test art. Mean 217.2 SD 15.6 n 2 8.647 1.087 2 39.73 2.16 2 240.8 4.7 2 10.681 0.325 2 44.39 2.22 2 4.Test art. E 100003 E 100004 E 100001 E 100002 210.2 213.0 8.741 7.497 41.58 35.20 232.1 242.5 9.294 9.288 40.04 38.30 4.Test art. Mean 211.6 SD 2.0 n 2 8.119 0.880 2 38.39 4.52 2 237.3 7.4 2 9.291 0.004 2 39.17 1.23 2 5.Test art. F 120003 F 120004 F 120001 F 120002 198.3 214.4 7.182 8.079 36.22 37.68 248.2 226.6 11.125 9.102 44.82 40.17 5.Test art. Mean 206.4 SD 11.4 n 2 7.630 0.634 2 36.95 1.03 2 237.4 15.3 2 10.114 1.430 2 42.50 3.29 2 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 5 2 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 4 ---------------------------------------------------------------------------------------------------------------------- Terminal Body Weight & Liver Weight Data ---------------------------------------------------------------------------------------------------------------------- F E M A L E S Animal No. Day 4 TermBW G Day 4 Liver Day 4 r.Liver g/kg Day 14 TermBW G Day 14 Liver Day 14 r.Liver g/kg 6.Test art. G 140003 G 140004 G 140001 G 140002 214.5 224.4 8.305 8.422 38.72 37.53 224.8 218.0 8.469 8.494 37.68 38.96 6.Test art. Mean 219.5 SD 7.0 n 2 8.364 0.083 2 38.13 0.84 2 221.4 4.8 2 8.482 0.017 2 38.32 0.91 2 7.Test art. H 160003 H 160004 H 160001 H 160002 212.2 213.5 8.603 7.182 40.54 33.64 238.5 215.7 10.199 8.820 42.76 40.89 7.Test art. Mean 212.9 SD 0.9 n 2 7.893 1.004 2 37.09 4.88 2 227.1 16.1 2 9.509 0.975 2 41.83 1.32 2 8.Test art. I 180003 I 180004 I 180001 I 180002 199.6 225.7 6.684 7.309 33.49 32.38 223.0 233.2 8.296 11.915 37.20 51.10 8.Test art. Mean 212.7 6.997 32.94 228.1 10.106 44.15 SD 18.5 0.442 0.78 7.2 2.560 9.83 n 2 2 2 2 2 2 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 5 3 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 5 ---------------------------------------------------------------------------------------------------------------------- Terminal Body Weight & Liver Weight Data ---------------------------------------------------------------------------------------------------------------------- M A L E S Animal No. Day 28 TermBW G Day 28 Liver Day 28 r.Liver g/kg Day 42 TermBW G Day 42 Liver Day 42 r.Liver g/kg Control A 010005 A 010006 A 010007 A 010008 324.0 336.0 12.331 12.325 38.06 36.68 334.1 378.1 11.409 14.802 34.15 39.15 Control Mean 330.0 SD 8.5 n 2 12.328 0.000 2 37.37 0.97 2 356.1 31.1 2 13.106 2.399 2 36.65 3.54 2 1.Test art. B 030005 B 030006 B 030007 B 030008 334.1 287.6 11.979 10.361 35.85 36.03 351.8 358.4 13.057 13.980 37.12 39.01 1.Test art. Mean 310.9 SD 32.9 n 2 11.170 1.144 2 35.94 0.12 2 355.1 4.7 2 13.519 0.652 2 38.06 1.34 2 2.Test art. C 050005 C 050006 C 050007 C 050008 366.0 315.6 13.691 11.344 37.41 35.94 361.1 392.9 14.927 15.148 41.34 38.55 2.Test art. Mean 340.8 SD 35.6 n 2 12.517 1.660 2 36.68 1.04 2 377.0 22.5 2 15.038 0.156 2 39.95 1.97 2 3.Test art. D 070005 D 070006 D 070007 D 070008 329.3 324.5 11.821 12.279 35.90 37.84 364.1 381.4 14.366 13.176 39.46 34.55 3.Test art. Mean 326.9 SD 3.4 n 2 12.050 0.324 2 36.87 1.37 2 372.8 12.2 2 13.771 0.841 2 37.00 3.47 2 4.Test art. E 090005 E 090006 E 090007 E 090008 335.2 324.7 11.747 12.948 35.05 39.88 372.9 410.2 13.484 15.394 36.16 37.53 4.Test art. Mean 330.0 SD 7.4 n 2 12.348 0.849 2 37.46 3.42 2 391.6 26.4 2 14.439 1.351 2 36.84 0.97 2 5.Test art. F 110005 F 110006 F 110007 F 110008 338.6 326.1 13.507 12.174 39.89 37.33 366.9 388.1 13.774 14.574 37.54 37.55 5.Test art. Mean 332.4 SD 8.8 n 2 12.840 0.942 2 38.61 1.81 2 377.5 15.0 2 14.174 0.565 2 37.55 0.00 2 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 5 4 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 6 ---------------------------------------------------------------------------------------------------------------------- Terminal Body Weight & Liver Weight Data ---------------------------------------------------------------------------------------------------------------------- M A L E S Animal No. Day 28 TermBW G Day 28 Liver Day 28 r.Liver g/kg Day 42 TermBW G Day 42 Liver Day 42 r.Liver g/kg 6.Test art. G 130005 G 130006 G 130007 G 130008 340.1 294.7 12.187 11.241 35.83 38.14 346.5 382.2 13.360 13.479 38.56 35.27 6.Test art. Mean 317.4 SD 32.1 n 2 11.714 0.669 2 36.99 1.63 2 364.4 25.2 2 13.419 0.084 2 36.91 2.33 2 7.Test art. H 150005 H 150006 H 150007 H 150008 319.6 331.6 11.292 13.481 35.33 40.65 328.2 350.6 11.791 13.423 35.93 38.29 7.Test art. Mean 325.6 SD 8.5 n 2 12.387 1.547 2 37.99 3.76 2 339.4 15.8 2 12.607 1.154 2 37.11 1.67 2 8.Test art. I 170005 I 170006 I 170007 I 170008 330.9 318.1 12.665 11.640 38.27 36.59 372.2 399.0 13.901 15.179 37.35 38.04 8.Test art. Mean 324.5 SD 9.1 n 2 12.152 0.725 2 37.43 1.19 2 385.6 19.0 2 14.540 0.904 2 37.69 0.49 2 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 5 5 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 7 ---------------------------------------------------------------------------------------------------------------------- Terminal Body Weight & Liver Weight Data ---------------------------------------------------------------------------------------------------------------------- F EM A L ES Animal No. Day 28 TermBW G Day 28 Liver Day 28 r.Liver g/kg Day 42 TermBW G Day 42 Liver Day 42 r.Liver g/kg Control A 020005 A 020006 A 020007 A 020008 232.1 258.3 8.001 10.907 34.47 42.23 256.6 280.3 8.409 9.276 32.77 33.09 Control Mean 245.2 SD 18.5 n 2 9.454 2.055 2 38.35 5.48 2 268.5 16.8 2 8.842 0.613 2 32.93 0.23 2 1.Test art. B 040005 B 040006 B 040007 B 040008 249.1 234.8 9.177 8.594 36.84 36.60 265.1 268.7 8.229 9.461 31.04 35.21 1.Test art. Mean 242.0 SD 10.1 n 2 8.886 0.412 2 36.72 0.17 2 266.9 2.5 2 8.845 0.871 2 33.13 2.95 2 2.Test art. C 060005 C 060006 C 060007 C 060008 231.7 245.6 10.087 8.372 43.53 34.09 248.3 258.1 9.031 9.128 36.37 35.37 2.Test art. Mean 238.7 SD 9.8 n 2 9.230 1.212 2 38.81 6.68 2 253.2 6.9 2 9.080 0.068 2 35.87 0.71 2 3.Test art. D 080005 D 080006 D 080007 D 080008 272.3 252.6 11.389 9.243 41.82 36.59 241.9 252.8 8.270 8.146 34.19 32.22 3.Test art. Mean 262.5 SD 13.9 n 2 10.316 1.517 2 39.21 3.70 2 247.4 7.7 2 8.208 0.088 2 33.21 1.39 2 4.Test art. E 100005 E 100006 E 100007 E 100008 237.7 219.0 6.943 9.557 29.21 43.64 251.5 278.0 9.509 11.309 37.81 40.68 4.Test art. Mean 228.4 SD 13.2 n 2 8.250 1.848 2 36.42 10.20 2 264.8 18.7 2 10.409 1.273 2 39.24 2.03 2 5.Test art. F 120005 F 120006 F 120007 F 120008 252.8 254.1 10.627 11.849 42.04 46.63 257.9 259.2 9.423 9.128 36.54 35.22 5.Test art. Mean 253.5 SD 0.9 n 2 11.238 0.864 2 44.33 3.25 2 258.6 0.9 2 9.276 0.208 2 35.88 0.93 2 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Ex p . U n i t = A n i m a l Fraunhofer ITEM Fi nal R ep ort 0 1 G 0 0 0 0 2 [Appendices A-D ] 28 Day Repeated Dermal Contact Study of 3M Test Articles in Sprague-Daw ley Rats P ag e 5 6 of 5 6 _____________________________________________________________________________________________________________ 2 8 -D a y R e p e a t e d D e r m a l C o n t a c t S t u d y o f 3 M T e s t A r t i c l e s i n S p r a g u e -D a w l e y R a t s F r a u n h o f e r -I n s t . f . T o x i k o l o g i e u . A e r o s o l f o r s c h . Study : 01G00002 Species: Rat Sex : Both A l l s u b -s e t s Page : 8 ---------------------------------------------------------------------------------------------------------------------- Terminal Body Weight & Liver Weight Data ---------------------------------------------------------------------------------------------------------------------- F E M A L E S Animal No. Day 28 TermBW G Day 28 Liver Day 28 r.Liver g/kg Day 42 TermBW G Day 42 Liver Day 42 r.Liver g/kg 6.Test art. G 140005 G 140006 G 140007 G 140008 237.3 248.6 8.024 8.110 33.81 32.62 245.4 260.8 8.967 9.491 36.54 36.39 6.Test art. Mean 243.0 SD 8.0 n 2 8.067 0.061 2 33.22 0.84 2 253.1 10.9 2 9.229 0.370 2 36.47 0.10 2 7.Test art. H 160005 H 160006 H 160007 H 160008 251.6 244.6 10.795 8.330 42.90 34.06 219.9 255.9 6.636 9.001 30.18 35.17 7.Test art. Mean 248.1 SD 4.9 n 2 9.563 1.742 2 38.48 6.26 2 237.9 25.5 2 7.819 1.672 2 32.68 3.53 2 8.Test art. I 180005 I 180006 I 180007 I 180008 237.5 250.2 9.872 10.574 41.57 42.26 257.2 295.7 8.521 11.082 33.13 37.48 8.Test art. Mean 243.9 10.223 41.91 276.5 9.802 35.30 SD 9.0 0.496 0.49 27.2 1.811 3.07 n 2 2 2 2 2 2 ---------------------------------------------------------------------------------------------------------------------- Statistics: Anova + Dunnett's tests. ( T w o -S i d e d ) * P<=5% ; ** P<=1% ; Exp.Unit = Animal *** END OF REPORT ***