Document 0wYGnd7v9oQKmvpqNXKRMe3k

EM O RANDUM DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION I-- t z e .ViSV-.V*'-V.V ; Dr, Robert M, Schaffner, Director Office of Technology (BF-AOO) 1973 )M : Dr, A lf r e d W e is s le r , A c tin g D ir e c to r D iv isio n o f Color Technology (BF-A30) ijECT: Summary and Comments on P ro f. Lewi n ' s A n a l y ti c a l R e s u lts f o r A sb e sto s in Talc 1. The p u rp o ses of t h i s memorandum axe to p r e s e n t s summary o f th e a n a ly tic a l r e s u lts fo r asb esto s in Cosmetic talcum -type powders o b tain ed by P r o f , Seymour Z. Lewin o f New York U n iv e rs ity i n h i s r o l e o f c o n s u lt a n t t o FDA; to compare h is r e s u l t s w ith th o s e o b ta in e d by o t h e r l a b o r a t o r i e s on some o f th e same sa m p le s; and to make some comments on th e gen e ra l question of su ita b le techniques fo r the an aly sis of asbestos in ta lc , 2. I ask ed Dr. Lewin in December 1971 to u n d e rta k e a s b e s to s a n a ly s e s in 100 sam ples o f cosm etic pow ders; th e scope was expanded on two subsequent o c c a s io n s , to In c lu d e a t o t a l o f 195 sam ples. I chose Dr, Lewin f o r th is work b ecause he is an in te rn a tio n a lly -re c o g n is e d ex p ert on m in e rslo g ic a l c h e m istry and because he i s a member o f th e academ ic community and th e r e fo re lik e ly to be im p a rtial in a c o n fro n ta tio n between in d u stry and government. Furtherm ore, h is competence had p rev io u sly been recognized by i n d u s t r y (by v i r t u e of t h e i r own u s e o f him as a c o n s u lt a n t) w hich appeared to confer a d e s ira b le immunity a g a in s t p o s s ib le in d u stry a tta c k s on th e v a lid ity of the re su lts. 3. Dr. L ew in's fin d in g s a re shown in T able I; th e key to th e i d e n titie s o f th e numbered sam ples i s g iven in T able IV. P le a s e n o te a ls o th e ex p l a n a t o r y comments i n Dr, L ew in' e memo o f J u l y 1 0 , 1973, w hich i s an A ttachm ent to T able I, ho v a r ie tie s o f a sb esto s o th e r than c h ry s o tile (a s e r p e n tin e ) o r tr e m o lite (an em phibole) w ere found by Dr, Lewin in th e 195 Sam ples w hich he exam ined. As shown i n T a b le I , Dr, Lewin found d e f i n i t e in d ic a tio n s of c h r y s o tile i n 17 o f th e sam ples (many o f th e s e a lso had tre m o lite ) and d e f in ite in d ic a tio n s o f tre m o lite but not chrysat i l s in. a n a d d i t i o n a l 18 o f th e sa m p le s. These r e s u l t s w ere o b ta in e d p r im a r ily by means of X-Ray d i f f r a c t i o n , supplem ented in some c a s e s by o p t ic a l m icroscopy and o th e r te c h n iq u e s . However, Dr. Lewin p o in ts out on page 2 , p arag rap h 1 o f th e T ab le I A ttachm ent t h a t th e c h r y s o t i l e he has i d e n t if i e d in commercial p ro d u cts shows se v e ra l s ig n i f ic a n t d i f fe re n c e s from " c la s s ic a l" c h ry s o tile : in th e lo c a tio n o f i t s X-Ray d i f fra c tio n peaks, in its appearance under the m icroscope, in i t s r e a c tiv ity tow ard d ilu te a c id , and in i t s b e h a v io r w ith re s p e c t to d i f f e r e n ti a l therm al a n a ly sis. DEPOSITION EXHIj INO.. ( b 7 i Kathleenmanes EVANSECPOemf,API PLAINTIFFS EXHIBIT CAM-32 HHS00000197 CPC-BCALTRSCPT00001140 F g e 2 - Dr, R o b ert M. $c h e f fixer 4, In T ab le T I, I have compared Dr. L ew ie's r e s u l t s f o r ' tr e m o ite w ith t h o s e o b ta in e d f o r some o f t h e same sam ples a t FM (by means o f o p t i c a l m ic ro sc o p y ) and. a t t h e F r i s e r M inerals , P igm en ts, and M etals D iv is io n (by means o f X-Ray d i f f r a c ti o n ) . This comparison, which was un d ertak en in o rd e r to o b ta in a d d itio n a l inform ation on th e sam ples, shows good s end. - q u a n ti ta t i v e a g re e m e n t among th e t h r e e l a b o r a t o r i e s . Whatever q u a n tita tiv e d iffe re n c e s e x is t in th e amounts of trernolite found can be understood re a d ily os th e b asis of such fa c to rs as (a) p referred orien ta tio n o f p la te s and f ib e r s In th e packing o f th e X-Ray d if f r a c tio n sam p le, and (b ) in h om ogen eities In sample co m p o sitio n , caused f o r example by a ir lu tr ia tio n w ith in th e c o n ta in er when i t is shaken. 5. I n T a b le I I I , X h a v e compared Dr, L e n in 's r e s u l t s f o r c h r y s o t i l e w ith th o se -obtainM . f o r some o f th e same sam ples by fo u r o th e r la b o ra to r ie s ; th e a d d itio n a l two la b o r a to r ie s in clu d ed in th is p a r t o f the s tu d y a t e Coliitnhia S c i e n t i f i c I n d u s t r i e s o f A u s tin , Texas (who s e l l t h e Stone -apparatus fo r d if f e r e n tia l therm al a n a ly sis) end th e H ealth P r o te c tio n Branch Of th e D epartm ent of "N ational Hba-lth and "Welfare Of th e Canadian government in Ottawa. The agreement o f r e s u lts from d i f f e r e n t l a b o r a to r ie s i s much le s s s a t i s f a c t o r y -for c h r y s o t il e th a n t h a t d is c u s s e d above f o r t r e r o o l i t e , F or exam ple, samples 89 and 163 w ere found by Dr. L e v in to c o n ta in 5% and 101 o f c h r y s o t i le , r e s p e c t i v e l y , but c h ry s o tile was not found in th ese samples by th e .other la b o ra to rie s . A ls o , a p r e lim in a r y f i n d i n g o f c h r y s o t i l e I n -a sample- o f Johnson and Johnson Shower to Shower Body Powder h a s been d isp u te d by th e company, w hich c la im e d t h a t t h e i r own a n a ly s e s by S e v e ra l d i f f e r e n t te c h n iq u e s f a i l to show the. p re s e n c e o f c h ry s o tile The exp lan atio n : fo r these, d i f f e r e n c e s i s a t t r i b u t a b l e l a r g e l y to D r. "Lawin1E in c lu s io n in. t h e ter " c h r y s o t i l e 1* o f m in e r a l s p e c ie s which show s i g n i f i c a n t d iff e r e n c e s from c la s s ic a l c h ry s o tile , as discuss-ed in paragraph 3 -above. 6 . The d i f f i c u l t i e s in v o lv ed in a n a ly zin g t a lc and oth er samples fo r sm all, amounts o f a s b e s to s have been p o in te d o u t by many in v e s tig a to r s . I t is not su rp risin g th a t the re su lts of d iffe re n t laboratories- disagree som etim es, e sp e c ia lly in th e presence o f tra n s itio n a l o r a lte re d m inera l g ic a .! sp a c os. Moreover., with- re g a rd to th e tw o -v a rie tie s o f a sb e sto s o f c a n c a r h ere:, i t i s u n f o r tu n a te t h a t th e one- which, i s - a c l e a r i n h a l a tio n hazard, to man, nam ely c h r y s o tile , poses an i n t r i n s i c a l l y mor d i f f ic u l t a n a ly tic a l'p ro b le m th an th e other, fcrefiO lite, which has n o t y e t b e e n -shewn" t o p r e s e n t a- b i o l o g i c a l h a z a r d , T h is i s .due in p e r t, to t h e l e a s p ro m in en t X - r a y d i f f r a c t i o n peaks -of c h r y s o t i l e an d to t h e f e e t , t h a t th e fib e rs a re o fte n to o sm all to be seen in th e o p tic a l m icroscope. 7, I n c o n n e c tio n w ith a p ro p o sed new r e g u la tio n on th e s a f e t y o f c o s m e tic ta lc u m pow ders, we face th e problem of- s p e c if y in g an a n a l y t i c a l t e s t f o r a sb esto s which must be s a tis f ie d by th e powders i f th ey a r e n o t t o b e c o n s id e r a te d a d u l t e r a t e d . On t h e basis- o f in f o r m a tio n a v a i l a b l e a t p r e s e n t, X recommend c o n s id e ra tio n o f th e fo llo w in g procedure. The powders s h a ll be examined f i r s t by X -ray d iff ra c tio n , w hich has a s e n s i t i v i t y o f th e o r d e r o f V% f o r c h r y s o t i l e and somewhat' g r e a t e r s e n s i t i v i t y ftm r, b.nv -Av,41* HHS0000198 CPC-BCALTRSCPT00001141 Page 3 - Dr, Bobert H- S ch affn er fox tre m o llte , I f e ith e r sp ecies is found, con firm atio n th at th e' sp ecies i s p r e s e n t i n f i b e r form i s to b e o b ta in e d by o p t ic a l m ic ro sc o p y and e l e c tro n m icroscopy. T his i s n e c e ssa ry because treroolifce i s known to occur in a non-fib ro u s fo m , and th e X-ray d iff ra c tio n p a tte rn o f c h ry so tile i s th e Santa a s t h a t o f a n t ig o r i t e , a n a n - f ib r o u s f o r a o f t h e sam e.m in eral* The sam ple is considered adulterated i f th e presence of fib ro u s t r e a s o li te or c h r y s o tile - i s shown by th e above procedure,-. An a l t e r n a t iv e procedure, based s o le ly on o p tic a l microscopy (which i s a le s s expensive and m ore w id ely a v a ila b le tech n iq u e) m ight be proposed. However, the d i f f i c u l t y w ith o p t i c a l m icros copy a lo n e .is t h a t i t may co m p letely m iss th e p r e sen ce o f c h r y s o t i le i f th e f ib e r s .are submi e r a s c o p ie , w hich may w ell be th e case in fin e ly -r o ille d ta lc ; X-ray .d iffr a c tio n is not su b je c t to th is source of error. E n c lo su re s lfjtd W eiss1 e r , $ h , D, `.sAyutn-.v-.v.- --.--`--H. -. rtat-xri-," 8 HHS00000199 CPC-BCALTRSCPT00001142 FINAL B8FQBT X-ftAY K7W2SR DIFFRACTION ANALYSES P COMMERCIAL OOSHBT2C POWDEBS Fhlfgo= Sanala Tale C hlorite t 2 3 4 5 6 7 3 9 ID tx -t 13 14 is 16 70# ' 100# 99# 100# 95# 8o# 86# 95# 89# 93# 100# 60# 31# 100# <=<SJ 3# a Bd ,, r i p ,# had a 2# 2# 7# 2# 7# 3# 2# R odo H j 50# D do 7# ii d o 1# ado 3# 5# 2# 3# 2# 2# 2# nodo n*d0 2# Z io d d C&iS Quarts ru d Dol= m ite "t * n*cL R od* n 0.d e aQ t i d -ko d e Xi b d R o d i, Ita d o n .d o n,,da 3# n 0dc 2# n 0 d*. 2# n*d. lo d o 2# 4# R ode R oda 2#. H, R od 10# io d p 7# R ed. ^55 nodo -- Treni C alcite lite i R od* lu d . R od* rip d o R od* R id o ru d* ru d * R odo R .d * Ro d* R ada Hd do R *d* R odo R =d* R odo R od* n*d* R odo R od* R odo n*do` R* do H co R odo ttd o n> d0 R odo 't nod* 1 7 60# 30# 1 8 90# 4# 1 9 97# '1# 20 3 5 # ; ' 6o# 21 67#, 25# 22 59# 35# 23 42# 50# 24 94# 1# 25 95# 2# 26 95# # 27 78# n 0d * 28 cao20# 1# 4# 2# 2# i# 2# 1# 2# 2# 3# 4# 2# n*d* no dp 2# R ed* 4# 3# H udo 3# 3# R oda fte da Tlo d R *dU 6# 2# R odo T ie d u 3# 5# 3# iq d o R od R odo 2# tte d o R od* dip R od* E&r i c R odo ilp ta. R od* Ro do R od' i io' R od* 10# R id o tw c lo T lctic de R ed* R id o R odo n*d9 R edo" R do nodo R edo 29 ea n94# 2# 2#' npH o d io R sd 30 97# i# 2# UfreR e d * R odo R odo 31 47# 50# 2# 3# 8# Zipio R odo 32 CO# 7# 3# 2# 8# Hedp R ed* Ghryso*. Other tile J fe S ls g Zip i & Xio i o Il i R odo nodo Z ip ci 7 Z ia d p rie d o Ho d e Re de R ode T ld d fin d o R od* * Tipd p H id n*do zio d o n*d* R *d* 7 Calftidecyl Z n U n d sy l K aolin , Starch Re de 7 t R ed g R de R odo Z io d o Re d H odo K aolin , Mica Kaolin HHS00000200 CPC-BCALTRSCPT00001143 jisibSjs 33 55$ 34 78$ 35 78$ 36 o 8 i$ 3T 3 8 $ 36 870 39 94$ 40 670 4 i 33$ 4 a 8955 43 97$ m 3W8& 4s 66$ 46 4 8 $ Lj 98$ b 8 8 $ 4g 100$ 50 95$ 51 1 0 0 $ ' 52 87$ 53 90$ 54 S87$ 55 80$ 56 90$ 5T 80$ 58 96$ 59 s90$ 6 0 o a B6 o $ 6-1 38$ 6g . 85$ 63 8 7 $ 64 es80$ 65 a*7S$ 66 8 4 $ 6? 78$ 68 80$ 69 9 7 $ 40$ 7$ 5$ 4$ 50$ m 3$ 25$ 80 6$. lis 80 30$ 40$ Rede 4$ R0dc 5$ nd0 8$ 4$ 3$ 15$ 7$ 15$ l Lst Red 38$ 4o$ 20 20 50 50 50 130 150 10 Fhlogo*Olt . 20 Rede 4$' ' 3$ D olo M te 3$ 8$ Redo ' Rede 2$ &b4 5$ 4$ 10$ de nd 20 5$ Rede. 7$ 2$ n-s-d# Red Redo rio de Rede 2$. Rc de n 9do i63 3$ 3$ 2$ ixiod 0 3$ 3TOS Rede g$ 50 3$ Rode n#t# Red Rede 2$ is-d# OQr n 0d 0 cdjef n* de 20 Red, 4$ - 50 7 $ Rede Tlo d<> 2$ 4$ Rodo Redo 2$ Rodo u U n# d rudo nod0 nd lia-de HdQ .d rde Rede Rodo- g $ 3 $ ' n&d Red. 2$ 2 $ : 2 $ Red 4$ rio do da 50 4 $ Itado d e Xloic! iu d 4 . 3$ R ede rijii-o, io d-o Reda 5$ Red, fisd* 4$ Rode iedo tw do Rede .3$ do Rede 7$ Rodo ' 20 .d# iid<3 4$ " 3$ 1 .8 $ H^lp de 10$ 2$ 4$ 3 $ . 20 RotU 3$. Rede Rede 4 $ n^d 3$ - ' 3$ 3 $ Rodo d# Rad Red xi# d<? Rede Hc d-# 5 $ Redo 5 $ ' Redo He do 2$ QiryBO= 'OfchuMP o ste .Sisee&sg Rede \ Re-de Rad , Rede Rede Rede ade Redo M isa Rede Trd * Tit d# Rade Rodo Redo &dtf Rade Ti#dtf Tipid Rede Red <Si:efS -- Z n G ,K *oltj Red Redo Rede -EljdClo Red- Red* H# Redo " Ruda Redo de Red Rede Re do Rd Rede de fteti nd6 ? Redo Rodo Rodo Rodr. Rede <id5 . .Red* is do lfia^Xd S t i* eh n^ct# ZnStear Rs,d* Rede ii dl^ 5$ Redo T# el# Ta da Z n S tear. iodo iAad.^' 20 de A20 Rede Z ir S te sp i t Red * Rde -de iVoi.# HHS00000201 CPC-BCALTRSCPT00001144 paps 3 o m stS a. J g M J S i l s t & = s 4 t . , TO 60$ Bada: 5$ TI 85^ to $ ttad 2$ 72 86$ 5$ 3$ 4$ T3 08OfJ 10$ liado 3$ T4 90i cd Had ciodp 75 75$ 5$ Hado ^cLq 76 75$ d 5$ 5$ 77 91$ il,do 4$ 2$ ? 85$ 2% t$ 4$ T9 tif i fo c*u50$ 81 <ia0$ 5$ 4o$ n 4$ da liada m 1$ 6$ 32 sa78$ 83 *u84 84 oa.92S* I0SI5S' ca*86$ 12$ ' 6 4$ 0 0 4$ 5$ Bad Hada Hdo ilado da 86 85$ ST 88 61$ 89 60$ 9 55$ 9i m m ~ 55$ 94 a<>46$ 95 86$ 96 28$ '4$ 50$ Hod 1$ riodu t$ tie d* %$ 4$ `Badi* Hods 2$ Boda Hod 3$ 3$ ildo Ittida m 0 li*d0 3$ 4$ 4$ 5$ B$t 7$ a 04 ' 6# 6$ m 5$ 6$ 97 31$ 1$ 1$ 5$ 98 ea4$ Bada 3$ -e 99 ea640/$ Bada 3$ iudU .00 $a*8Q %o$ 4$ Ho-i3,0 1 '6$$ 8$ 0 7$ ,02 &%$ 2 $ - W& 3$ v03 3$ H,,de &Clf to4 90 3$ it Bolo flraift hj^s= O th ^ r - M i a 0& & jl $ t, - , ^ m & m 7$ Bada Bado Ka Bado 2$ .da CU .3$ . ad nd ad , 5$ Hada 5$ 5% 15$ 0 10$ Badi, Bada Bado 3$ ' Bada 0 -0 (lodo Badai oda a,da ZSt^ar ad* ad ad nd,, 5$ ad* 3$ ad 5* da liado- do ad ? 4$ Bada n*d ? 3$ Bado 4$ H%da ad oda 1 ? 3$ Hada 8$ Bade 4$ Tip.da do ? da ? do 12$ 3$ ada 2 0 da 4$ 5$ tQ$ odo 5$ 5$ 23$ 2$ 0 5$ u" 3$ 0 ed* 3 $ a 20$ ad*. 5$- 0 25$ Hada 0 4$ ^ 35$ 0 da 4$ % 4$ da 2$. 3,9 . 45$ ad 8$ %m -' 35$ Bada \0> 5$ ' 6$ 2$ da do Kaolla* Mina 6$ 2$ ndo cd* Eaolt Idea 2$ ad sd ad JSStaar 4$ do. 15$ Rd , 1 0 da ' % 0 7$ 4$ lodo do J&odie 3$ do ad* HHS000002Q2 CPC-BCALTRSCPT00001145 pagi 4 Ph|g*- t*i aiaole le le 0hlrite m 92# 3$ 1$ 2$ j06 91# 3$ ' 1$ . 3$ 07 87$ 5$ e$ ilo ,08 St$ 10$ 2$ 2$ ,09 74$ IO 99$ l i 42# 18 ea.s6$ . 15$ Tt'flfr'dLfc' 40$ Ho8 3$ 1$ 2$ n8d 3$ Redo lHp 4$ 43 79$ 15$ 53$ 40$ 53$ 40$ .16- . 53$ 40$ 17 42$ 35$ 18 59$ 40$ 19 k$# 40$ 20 46$ 4o$ ,81 87$ 8$ 22 58$. - 35$ 23. 51$ 4o$ .24 54$ 4o$ .25 55$ 40$ .26 75$:. io$ 27 85$ rude 2.8 60$ ludo m 97$ Rdo $9 ca83$ 7$ 31 a,92 3$ 32 95$ 3$ 33 94$ 2$ 34 93$ ' 3$ 35 .. 93$ 2$ 38 89$ 4$ .37 9 i$ 4$ 38 85# - .7$ 39 a#.85$' H&dp Hode lod Rode lud 3EVLo Red* 2$ JXod* ledo Hed XUd* 3$ deli.Lo lio0 Hede 3$ 2$ 4$ s$ 3$ 3$ .. 3$ Rade 3$ 3$ 3$ 3$ 15$ 3$ 6$ 6$ iu 5$ 3$ 3$ 2$ 4$ 4$ Hede Itede 2$ ilede Hede Redo Hede nodo .2$ 3$ 2$ S$- ,4o <sa085$ R ed* ned 2$ .isl&a 2$ 2$^ 6$ 3$ 3$ nodo 15$ ndo 7$ 4$ 4$ 4$ 4$ 4$ 5$ 3$ 4$ 4$ 3$ 3$ 8$ Rde Hede 3$ 3$ 2$ od. ned 2$ 2$ 2$ 2# 3$ lied 1$ Calelt . lite Rade Rode Redo Redo ned. XiadLg Rode to$ ticl Hede Redo 2$ 2$ lde 1$ Redo -1*1pdU Hird^ ode 2$ Hode * Redo nd. Hodo Jlede Iis.de i 4de Rede Sede TLoje Hede Redi n0d. nodo ned odo _nBda ri*de Red iloti nd -tigldl> Hede n ,d . tu A* Hade Hede n^<d-c? de lido i<sdo ft.ide Red fttdU Red, nodi Rad, Red ' fernet tra* Reds Ride Rido Rde Red Red, Red, ,, tii$d& nodo ned Ghpys tiier Redo H* tl& IbisdL-0 d,q 7 Racjin Ufido Red Rode Sfcltayli Ae.Berle Aod Rode Rode 'ode 'r Bgde Red, ? Red ? 7 7 ? Redo Red* - Brle Aedi TU(te da^nd#^,! Ila.die tracev Redi; HaGL* rioCr lti dU> Ticdi Rts.de HeCLr Rode Red EaSfcaar gC3 .EnSttar, $gC% HHS00000203 CPC-BCALTRSCPT00001146 1 4 1 GO/tf 142 792 143 550 1 4 4 oa57 0 2 145 oa702 H-eCo 7# 2# io 2 3# 1 4 6 o a 085$ 147 oa*S52 48 m A 5& 149 ca 502 150 3o2 1 5 1 6351 1 5 2 OSu 7Q2 n.d c Had 4O0 100 20 250 20 1 5 3 UOff 20 1 5 4 Cae?>2 155 a&842 156 792 1ST 63^ I 50 782 * 59 a* 742 ISO- 6o2 161 592 1 6 2 5-52 163 5 5 0 164 92# I65 9 2 # 166 c a ti50> | 6t 7 g 2 168 169' ttfS* 170 322 171 70# 172 4$2 173 0& .99& 174 c ito 60# 100 100 O 0 20 70 100 : '20 ' 5? 250 20 30 90 400 100 *F* ** Pedo l 2 500 12 na0 52 Ptd Etcd ndo tteds tWdU ned tic de n^ds nd nodo Sedo 4$ nodo nod* nodo ndo 20 A*tf ac! a d S# fi do Hodo Hod i ggaiga n sd0 Had* tied* tu d 20 20 40 30 60 tied 40 ned. Hede i 2 52 22 Hede Heda 4$ 40 60 30 30 ld sd 20 20 .^ a^d 0 Hado 2$ Hod *=ms* OV33 52 50 nade nada 152 D ole ssite G al lte C h u f e o Ofctasx* i2 50 250 ried-o 30 io-do a do 120 He do l 2 Hade fte do 20 20 30 i 82 20 40 40' 40 50 200 20 20 30 20 s a. 252 150 50 Hod nodo ned Had i#do tud* nod. 50 50 sud* |Xdo 52 tic do ilodo n .d 0 ad0 nod* n do nda io 2 t2; 402 |02 W0 riv t. lf d# Hoda rio d Hade t&ena nd n 0d a da ad t a d li* do node 50 50 tu do tud Tcdo 20 80 ttod Sede la de tic de 20 oda 20 50 n 0d. rude rt d ndfl .rio d 100 f tu do a . do a do ,0 t-ceitWS: ^0 He d# Pad 22 He do nodo Pad 2 n S t# r, MgCO^ podo 102 ? - SnStear K aolin 2 0 . EnStear K aolin. SnO Pede n S tea rc n fldo ito d K aolin 2a s t # a r Y K aolin tud* K aolin nodo a de F y n o p h y ll it ' Bdo ZnO, B o r ie A cid n 0d 0 ZnO 7 n*do 80 d ado ? tracSi Pad nd9 to 2 VJ' 10 ? ? tUd Oypaum *2H=t 82 rud ad ? Tde K aolin .Mica HHS00000204 CPC-BCALTRSCPT00001147 175 oa-8is0 30 176 cs790 30 i n 840 100 178 oa*5O0 200 79 970 !Rij'L..0i 180 800 IqCL 18! ca70 todt 182 ea4O0 18$ e&o760 100 1 930, 20 183 e*t5O0 80 186 ca500 50 1ST a830 50 186 700 150 1,8$ 20 20 190 oa*S20 120 191 960 20 192 1000 nd* 198, ca930 * 20 49^ es940 . 20 m 970 i-do p a g s 5- R ile g o - ok JB & L* &S& do 100 ,20 130 40 20 20 50 ndo 30 ada ndo mdc do 150 do cud ndB ede ;a0 d lp d* n#do nd0 20 20 30 Dodo 30 20 n#do <td &*U d H ndo 90 nd '0$file 0de sudo .- ,, ' BolM & S$l od do Tlde d d d 40 Rde d Rde - 120 Red Tte- 100 He ad 20 100 lud :d ode, 250 ild. 250 od. 50 40 50 20 50 30 Jinde 20 Ufi&* do ned* 20 lta 30 30 30 odo odo odo ds d nd do Redo d 10 30 kda n*du 20 10 10 i Sda nd db nd^ nd _ rays fchsr J t e . -g atfifs ? li od f Kaolin Rd nd ndo KaM 2n0 ? ds (led 20 T go nd ? adB od nd ZnStearo f d HHS00000205 CPC-BCALTRSCPT00001148 New York University Department of Cfiemiilrj 4 Washington Piace, Room 410 New York, N.Y, 10003 Telephone: (212) 598-3427 Memorandum to : B ri George Thompson Food and Drug A d m in is tra tio n From: S. 2, Lewin C hem istry D epartm ent, Mew York U n iv e r s ity Be: D eterm ination o f A sbestos C ontents o f Commercial Talcum Powders, T his w ill serve to summarize the m ain -p o in ts o f our d isc u ssio n on t h i s d a te o f J u ly 10> 1973 w ith re s p e c t, t o t h e f a c t o r s in v o lv e d In the d e te c tio n and estim atio n of ashes tod in ta lc , and the sta tu s of the ta b u la tio n o f r e s u lts of th e analyses; of commercially' a v a il able consumer products co n tain in g talcum powder. My r e s e a r c h group has b een engaged i n s t u d i e s o f t a l c and i t s a c c e s s o r y m in e ra ls c o n tin u o u s ly s in c e J u ly 1971* and we a re c o n tin u in g t o work i n t h i s f i e l d . We have u n d e rta k e n t o i n v e s t i g a t e th e fo llo w in g problem s: A, T a b u la tio n o f th e x - r a y d i f f r a c t i o n d a ta f o r t a l c and a l l s o lid phases (w hether n a tu ra lly o ccu rrin g ) o r added in the .course of p ro ce ssin g ) encountered w ith ta lc In m in eral, in d u s tr ia l, cosm etic and pharm aceutical products, B. E lu c id a tio n o f the x -ra y d if f r a c tio n spectrum ( I . e , , p rec ise l o c a ti o n s ' and r e l a t i v e i n t e n s i t i e s -of peak and v a r i a b i l i t y th e r e o f ) o f c h ry s o tile . Assignment of th e d if f r a c tio n peaks to the c ry s ta l p lan e s re sp o n sib le f o r them, and in te r p r e ta ti o n i n terms' o f c r y s ta l login phy of th e e ffe c ts o f g rin d in g , o rie n ta tio n , and sample p rep a ratio n , 0* I n v e s t i g a t i o n o f th e c h e m ic a l p r o p e r t i e s o f c fe ry B o tlle , a n tig o r lte , c h lo rite , tre m o lite , and t a lc ; s p e c if ic a lly , measurement of the ra te s of hyd ro ly tic and ion replacem ent rea ctio n s, B. M icroscopy, b o th o p tic a l and e le c tro n , of e h ry s o tile and of ta lc s containing various accessory m inerals, including e h ry so tlle and- tr e m o lite . E,, M easurem ent of th e d e g re e o f e n ric h m e n t, due t o a i r e l u t r i a tio n , . o f a sb e sto s i n th e l i g h t e s t f r a c tio n s o f th e d u st from oommarciaj HHS00000206 CPC-BCALTRSCPT00001149 i?. 2, - P* Developm ent o f a m ethod based on th e c o m b in a tio n of x -ra y d iffra c tio n , chem ical r e a c tiv ity , and m icroscopy fo r th e estim atio n of the c h ry s b tile and trem ol i t a co ntents of consumer products (these two b e in g th e o n ly a s b e s tlfo rm m in e ra ls e n co u n tere d in a l l th e American products- examined s o - f a r , w ith only one p o ss ib le e x c e p tio n ),_ and a p p lic a tio n of th e method to the a n a ly s is o f about 200 sta n d ard sto re -p u rc h a se d specimens-, G-, I n v e s t i g a t i o n o f a l t e r n a t i v e a n a l y t i c a l m ethods, v iz , d i f f e re n tia l therm al an aly sis and d en sity g rad ie n t c e n trifu g a tio n , as a lte rn a tiv e or supportive techniques * Our r e s u lts to date su p p o rt th e fo llo w in g co n clu sio n s: 1, The c h ry so t i l e t h a t i s found i n com m ercial t a l c s i s g e n e ra lly , d iffe re n t in s ig n ific a n t resp ec ts from -the ehrys-otile th a t occurs as m assive, fib ro u s growths in v ein s in, s e rp e n tin e rocks*. That i s , th e fo r m er has d iffra c tio n , peaks th a t m y d i f f e r from the l a t t e r by as-much a s 0 ,2 A ( a t 7*3- &}$ I t I s more r e a c t i v e to w ard d i l u t e a c i d s ; i t shows a d i f f e r e n t ap pearance u n d er th e m icro sco p e; and i t s ISA endo- therms and exotherm are s h if te d r e la tiv e to th ese of th e l a t t e r (and apparently dim inished}, 2, The p re s e n c e o f c h ry s o t i l e .as a m inor c o n s titu e n t i n t a l c may be e sta b lish e d w ith reasonable c e rta in ty on the b a sis of (a) the p resen c e o f x -ra y d i f f r a c t i o n peaks i n the- v i c i n i t y o f 7 .2 3 to 7,43 A and 3 .5 9 to 3 .6 5 A, (b ) th e pronounced' w eakening o r c o n f e te d is a p p e a r ance of th ese peaks upon treatm en t o f the specimen w ith 1 W HG1 a t $0C f o r 1 h o u r, ( c ) -the- p r e s e n c e o f f i b e r b u n d les o f v i s i b l e s i z e u n d e r 2.5OX o r h ig h e r m a g n if ic a tio n i n th e o p t i c a l m ic ro s-cope Which Show a r e f r a c t i v e in d e x o f about- 1 5^ ( th e s e f i b e r b u n d les may be s h o r t and s t r a i g h t , and map be c o a te d w ith a humpy e n c r u s t a ti o n o f M g c!^, o r m y be embedded In ta lc o r o th e r p a r tic le s ) , and (d) the presence o f fib e rs under th e e le c tro n m icroscope which y ie ld an e le c tro r d iffra c tio n p a tte rn th a t corresponds in, d-values to those found in the x -ra y d i f f r a c t i o n p a tte r n (th e s e f i b e r s ty p ic a l l y do n o t have a hollow c e n tra l c a p illa ry running through them ) 3 , The c o n c e n tr a tio n o f c h ry s o t i l e in. a t a l c may be e s tim a te d by Pleasuring th e area under th e x -ray d if f r a c tio n peak a t about 7-3 A " * * * - 1---t- -* y, int-j-rhal s t a n d a r d . The b e s t i n t e r n a l s ta n d a r d HHS00000207 CPC-BCALTRSCPT00001150 ' - 3- is calcium o x a la te monohydrate (peak a t 5.83 A), 4 , Tiie q u a n t i t a t i v e r e s u l t s a r e c o n d itio n e d by th e f a c t t h a t segregation, e ffe c ts in ta lc powders a re c o n sid era b le j th e a n a ly tic a l method gives a re p ro d u c ib ility o f 12 to 30 average d e v ia tio n in .r e p l i c a t e ' d e te rm in a tio n s on th e same sample* b u t d i f f e r e n t sam ples from th e same b u lk c o n ta in e r a r e found t o v a ry by a s much as 2000, 5 The q u a n t i t a t i v e r e s u l t s a r e f u r t h e r c o m p lic a te d by th e fact^ th a t s n tig a r ite gives an x -ra y p a tte rn th a t i s in d istin g u ish a b le from t h a t o f e h ry s - o tile . The KCi tr e a tm e n t s p e c i f i e d above does n o t a f f e c t ground a n t i g o r i t e j h u t i t i s n o t y e t known w hether a n t i g o r i t c , i f i t o c cu rs i n ta lc * has th e same chem ical r e a c t i v i t y as th e ground m t e r i a l from m assive aatigorlb.e-, or w hether (lik e e h ry s o tlle ) i t s p r o p e r t i e s may be v a r i a b l e depending upon th e ro c k m a trix I n which i t is found. 6 . S u b je c t t o th e q u a l i f i c a t i o n s . I n h e r e n t i n th e above* we have o b tain ed -q u an titativ e estim ates of th e ch ry so lite contents of about 200 com m ercial ta lc u m powder sp e cim en s. We have a lg o d e te rm in e d th e contents of the o th er m inerals in -th e se products* -including trerao lite, quartz* c h lo rite , dolom ite, and o th e rs. There i s no am biguity in the Id e n tific a tio n of these la tte r species, b u t.th e q u an titativ e r e s u l ts f o r th e se a re a ls o a ffe c te d by th e segregation problem , which i s most se rio u s f o r th o se c o n s titu e n ts present- i n th e sm a lle s t amounts, 7 . h o st of th e commercial ta lc s te s te d are fre e of any d e te ctab le am ount fef any o f t h e a sb e .s tlfo rm m in e r a ls , a c c o rd in g to th e c r i t e r i a enum erated above. Thus, th ere appears to be an adequate supply of t a l c f o r which th e re i s no am biguity ab o u t th e absence o f c b ry s o tile o r trem oldbe. In about t'00 o f th e sam ples te s te d , th e re appear to be d e f i n i te l y d e te c ta b le amounts o f e it h e r e h ry s o tlle o r tre m o llte p re se n t. HHS00000208 CPC-BCALTRSCPT00001151 TABLE I I rSTElLABOM'fC'Ri' o0HPABI$0n OF ANALYTICAL KESOLTS FOB TREMOLXTE IN COSMETIC TALCOM-TYPE POWDERS SAMPLE NO. H. ILK. (XMY DIFFRACTION) RESULTS m (OPTICAL MICROSCOPY) (X- SAY DIFFRACTJON) 1 n.d. (not detected) 2 n. 4. 3 n. d. 4 n. d. 5 tu-.i. ! 6 tl:, 4. 7 n , d* 8 rud.. 9 n, d. 10 tu d . XL n.,d* 12 Tit d( 13 tud. 14 a, d. 15 16 n .d , w,C 17 iu d . IS n.d. 19 n, d. 20 a. d. 21 n*d. 22 nd. v.Vi.v.- h"TT,--!K.TT^V K'^Cf.V^i-iA fiScaz'sfz.i C.UKV'SVIV' WWBW?W' trissiststi 5 i iS4;^:r ftS53?,-*y :: Ail}'?*:- HH $00000209 CPC-BCALTRSCPT00001152 SAHPL NO, 23 24 25 26 27 28 29 30 31. 32 33 34 35 36 37 38 3940 4X 42 43 44 45 46 47 48 __________________________________ LY-U, RESULTS FD (-jLKX. BXS^BACTIOIO (OPTI Gi. MICROSCOPY) n, d. TU n, d- a*d * n . d tu d . ru d. tu d* -d . ru d, n el a* d- a . n, d. o . d a, d. nd. a* d- n.<L n -d . a , d -- a- d r. d - id. n .d * PFX2E.R fX-BY P^PECTIQlO saiStififTi 5V.VA-,>.V.-^-. jprsfF-WT' fssttiiiv & fz: viW iefi.'r f t i i I ^ESM*Kl!l^ET5*t-;e<w w #*me*1<if-#k-e* Jif HHS00000210 CPC-BCALTRSCPT00001153 5HP. NO. 49 50 51 52 53 54 55 5& 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 N. Y, ti. X $ 4 iI^ E S m M l. n . . tutL ; d. n, d. 'tt*' . tu d, n, d. n, d. n . d. n. d. n. L , d. . d. tu d . 5% tucL n .d . tu-d. 21, eu d* n .d . n. d. 31 n. d. n, d. n. d. results FDA. (OPICAL KLCRSCOP) n. d. n .d . n . d. M oderate amount sm all amount u,d,, tu d. HTsll &mou&t PFIZER !/f.\ *. t i t : r; 1i^itii liKV.iSj -'V-.v r.v-%' ------------------------ ---- A----i-- ---- - HHSD0000211 CPC-BCALTRSCPT00001154 S A M H HO, 75 76 77 78 79 80 81 82 83 .U 85 86 7 88 8S 90 91 92 93 94 95 96 97 .98 99 100 K, Y,U. (X-RAY BIFFBCTZOB) n.d. 5% 3%. 57:, il, d. a , d. n. d, n. d, n. d. ti. d, TL,d, n. d. tud. 4% 51 31 n. d. 51 5% 4% 21 m* 12% n, d, a .d , tt.d . -- .____ JigJJLTS,......... FM (OPTICAL KiatOSdOPY) PFIZER QC-RA.Y jDIFFa&CrXOW) sia a ll am ount m oderate, amount n, d. tt.d-. n, d. la rg e amount la rg e amount la r g e amount la rg e amount la rg e amount la rg e amount m oderate amount la rg e amount a, d, v e ry sm all amount ' 1. 61 1,91 0.71 8.1% . t ' i i r . r . ! . ! -'- ~ Jlvmwa: ii hVLlYI.*.": Irr-vi/.',-".1 J7iit,ri; j.Vl.nt'a.VJ,- BE EE gs CPC-BCALTRSCPT00001155 SAMPLE IS., 101 102 13 104 105' 106 107 IOS 109 no in 112 113 114 115 116 11.7 116 119 no 121 122 . 123 124 123 126 my, o, (X-RAY DIPFRACTIOlO 15% W1 fn L a*d. tud. n-d, tt-cL 2% 2% rud* it n-d* . n, d. n, d. fi,d. a. d. n, d. n- d. n. L a. d. m<L n. d. ti-*( n. d. ti,d, n, d. ,, .R E S U FGA ' ' (optitax M~j.crRGsco.py') L T S _________ PFIZER o ray MFFMcrxom larg e amount 10 to 15% la rg e amount u- a. U- e= 2 sjsiSarS;q;s bHW=SiSsliKr pu&rfe-j f I tliv itif : j r T- : W&VW wwaMWWH SfSJi S'! HHS000213 CPC-BCALTRSCPT00001156 SAMELE 0-. 127 128 129 130 131 132 133 134 135 136 137 38 133 14 141 142 143 ` 144 145 146 147 148 149 51S 151 152 JLT. U, CK-I&Y DIFFSA.CTI ON1 n. d. U, dn.-- t 'tX&C6 trac l d-* ,n. d. tu d . n, d. r.. d. 2.*--dit* n. d. ii.dL H. C, r , d. , d. 5% 5% n . fl n*d* n* <L 2?b m n, d. n .d . i*d. RESULTS ' ' " FEA. (OPTICAL MICROSCOPY} PFIZER (1-BAY DFFRACTOSi) sm all amount pTesant tu d . f*?VWjWf- iVi.V^.Kii'^.i HHS00000214 CPC-BCALTRSCPT00001157 SAMPLE NO, 153 154 155 156 157 15.8 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 H. Y*U. .g-RY BIFFRACTIOH) cl. d. 2% n. d. 27 67 ti d. eu d. n. dT El. d. Eu d* 10% ti d. Eu d . lud. 27. -4 wL ud. ie'J&Sf *v . d. xu Cu ri. d. n d n. d. xud. RESULTS ________ _____________ _ _ _ FM. PFIZER (OPTICAL MICROSCOPY) (X-M.V DLFFBA.CTIK) s n a il 'auitswnfc apptox. 0, 57 la r g e amount n. d. 3.8% - Tiriiri.-'IXV. Isi.V* 7.v,r^ S HHS00000215 CPC-BCALTRSCPT00001158 SAMPLE NO. 17 & ISO 181 182 183 184 185 186 1S7 1S8 189 190 191 192 193 194 195 ________________ RESULTS N .I'.U . fX-RRV DlFFRACTIOm n- dru d. n. drt. d. It 3% n,d. n, d. t% 1% n n-drud. n.d. n. d, .tt. d. n,d. FM fOPTICAL MICROSCOPY) PFIZER fX~gAY DIFFRACTION) Foojfnotga ; a, 'Stork' done by Mr, Arnold. E, S c t a l z a , D iv isio n o f M icrobiology,- (S ee Appendix A) b , Pfizer, I n c - r M in e r a ls ,, P ig m e n ts, an d M e ta ls D iv isio n ., Eastern, pa , c , The u s e o f a d a s h means t h a t t h e pow der does n o t. contain t a l c and t h e r e f o r e is n o t e x p e c te d to c o n ta in tremolite o r chrysotile as contaminants- Wo a s b e s to s w&s foetid. .W H'i -IiW rivrit'tvfrr VtirV.WliW*' x t iX&k v .-. WM r-- W7JJW* fc ~ :r; n n ii'.K iii Sitr;tt-K jftn & fz -'. |VASAAii ^ HSKr i rs v i.v w W.VAVlt. tW vV iV *, v-rif-rT A'S'UAV.V KHS00000216 CPC-BCALTRSCPT00001159 3AHPLE NO, , 1 2 3 :4 5 6 7 B 9 10 II 12'. 13 14 X5 16 17 18 19 20 21 22 I&ELS III, IHXESIABBAIOa COMMjRLS OF ANALYTICAL HESOLTS FOE CHRYSOTILS US COSMETIC TALCUM-TYPE POWEERS K, Y.U, CX-RY DUT. ) Em o l s FIFI PFIZER*- (OFT, MICR. 1 {X-RY DIFF- > -tu d , (tujfc d e te c te d ) COLOMBIA SCIENTIFIC n . d. a. d. n. d. a. d. a.d. % T.#J.#- Hl* Ci* TU , TL. d. r.. d. a . d,. a. d. 71. . a. d. n. d. radn . d a, d. n,. d. HPBC AteWrAVtf-W/ Er.'r~H PWH'WmWV 7lJM*7,V7^"r,.'.T'-T7V'V`,7t"7 7S.t*ziz\': cr-ya^AV.*/" wv"^f|v' fitilTSS J'Si?S4r.>- --U'rt'-L. Hv&aS.i".*' WMftUzt* T'V.IVMfi# Wt.VAtLS.V. 9*ifrmf3iT F.Vl'iii ihrtVlVfe.l VStiVOAV..* SES SSiS H ";" S!JW? SEE."!h'E'iM**' HHS00000217 CPC-BCALTRSCPT00001160 &HPLE NO. 23 24 25 26 27 28 29 30 31 32 33 34 25 36 37 38 39 40 41 42 43 44 45 46 47 48 N. (X-ft ? rt. <i. ? 3 tu dtad. Tt. d. ta d. n . d* it., cL la d . ta d . n* d, a. d. n. d. it, 4 . tv. d. u .d . .ta d. eu d. ru d. ** n. d. n, d. ra d. ta d . RESULTS ....r m 1 ' "p rriijF " (OPT, MICE, ) (X-SAt BIFF. ) COLUMBIA. SCIEHTIplCb EPBC ! pTM4 3 HHSQ0000218 CPC-BCALTRSCPT00001161 SAMPLE J^,, 49 SO 51 52 53 .54 55 56 57 58 59 m 61 62 63 64 65 66 6? 68 69 70 71 72 73 74 N.Y.U. tu d. Tl- <L XL--d ti. d. tl- d- *1 n ,d au A. u. d. n ,d . n ,d . ti, A, n , d* b. d. n .d n, d, a , d. 2% a,- d, tadn.d n, da- c. a, d-- a* d n. &. RESULTS FDA FFIZER (OFT- MICK- >. (S'-MY DIFF, ) COLUMBIA SCTEHTIPICb HFBC a, d. a, d. nd. n-d* & d. a , dii- d. tt.d . iff. 'HW HHS00000219 CPC-BCALTRSCPT00001162 SAMPLE no. 7$ 76 77 78 79 $0 81 82 83 84 85 86 87 88 m 90 Y .,y .0. Ql-BAY BIT?. j n.d. n .d . n .d . n .d , n .d . ? f ? 1 ? ? ? 5% 5% 5% 91 3% 92 5% 93 A t 94 1 95 3% 96 10% 97 15% ftESDLTS ___________________________ FD ' PFIZER*- COLUMBIA (OFT. HICE. ) (X-RAY KEFF, ) SCIESTIFLO^ KPBC n .d . n .d . n .d . a. d. ti.d. ti, d, ru d. possible^ in ta lc grains a , d, possible.;, in ta lc grains much aatigort f n. ci possible,, in ta le grains moderate ant igoriteS a. d. n. d. in c o n e lu s XVe inconclusive in c o n c lu s iv e <0*1% in c o n c lu s iv e ssxnr S 1M!W.SS v'r'i'.VC.'. r T" E v , t!` EE HHS00000220 CPC-BCALTRSCPT00001163 AMPLE NO, 98 99 100 N, Y. U, CX-KAY B IF F .) tu d. tu d ft. d. 101 f t , d* 102 7% 103 xi* d * 104 ii, d, 105 iu d . 106 ru d . 107 tu d . 108 XX'd 109 7 n o ru-d. i n ft.d. 112 iu d*113 JV-fd * 114 *ud. 115 ,,tu 4116 n, d. 117 1 118 ft, d. 119 it. d. 120 7 121 f t , <3, 122 t msmjm FM 'FIZER*- (OFT. MICE, ) S -EAY DIET.) tu p o ssib lej lit ta le grains Tnueh a tgorite? a. d. ft, <L n- 4, COLUMBIA SCIENTIFIC" HPBC ft, 4 ii toitW.Vtr.'w -gJir-TT^jLmtx:r- Se*fr?-vier.TA': ilViVLitsur;%i.-\ fiffK-WS R3tVS'A'*ft TffrA"/?.-.' FMfp'.-ri*, mtsjumtfr- m:Pis.Vv,>t^ w3viwtt.i4v:. iTZ-zman? VarKiV "SSunyr iwc **.;r4,.-rJ f'&ttrj'f .RiliJP ^TvsWif AitfePi u\-& mr\A- iKKSVV.'f sr-irstt: ijifc'y ffrisi.** P _________ _ --------- SSPiSiVA^TOTMWkSSliTia HHS00000221 CPC-BCALTRSCPT00001164 &MP1E NC. 123 124 125 125 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 1*2 143 144 145 146 147 148 N.Y {x~m? ? i j EUd. n. d. tu d., tu d. Trace a d. n*d. tu d. tu d . tu d. tu d. tu d. n, d. tu d . Hz d ru d. n , &. 10% *j 2% n, d. H CL# ti, d. -py3"- KB"S~UxXJS COF f. MICB. ) a - ' m PIFF. ) cmUMBIA SCIENTIFICA HTBC Jk'W'-.V,irJVW^* i-iiA'.'W'rii uvuvsm vvar ^aytrvj.vH^' H. d. fEit<*y- iiiSW.pS'USr rzttirrtiin; I-.ss'EuuF -^-pVAV^: sjss/.w *: :v AtioraWAfci <5Mer;32tti'i n:.:puu-; WrJaWiii. liffi'S-Et'ii pVTit feil.",tuli i" `,," HHS00000222 CPC-BCALTRSCPT00001165 AMP' SO, 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 X65 166 16? 168 169 170 in 172 m 174' H,Y,tL CX-fe? 01FF. i ? m d. n .d . n .d , u ,d . n , d* ? n, d, 8% n .d , 2 trace cl, d, n .d . 10% 1% 1 2 xi, d, RESULTS FJDb. P F I Z E R * " O T D f f l S " (OFT, MICE, ) (X-RAY DXFF. ) SCIEMTlFICit n, d, n .d , n .d , 0.17*e n .d , ttid , possible, in ta lc grains n.d. ' in c o n c lu siv e HFBe 8% n, d, ' ii, d* 9 m d, ".Vliy"''"L' w i wi>"rv . i7Ar"7* HHS00000223 CPC-BCALTRSCPT00001166 SAMPLE HO, K.Y.U. CX~SAF DIFF./5 RESULTS FDA FFXZERa (OFF. M1CR, ) fX-MY B if f , > COlSHBIA SClEHTlFICb HFBC 175 i 176 ? 177 n. <L 178 7 179 ru d. ISO n. d. 181 n ,d ,, 182 183 t 184 n . d. 185 n. d . 1S6 ? 187 n .d . 188 ? 189 n . d. 190 ' ? 191 n- d . 192 n , dv 193 ? 194 7 195- it* d . . 'ootnotes t ffisse r, Inc. , M inerals, Pigm ents, and M etals D ivision, E aston, Pa, Columbia S c ie n tific . I n d u s tr ie s , A u stin , T exas, u sin g D if f e r e n tia l Thermal A n aly sis. H ealth. P r o t e c t i o n B ra n d ', o f C anadian G overnm ent, O ttaw a , b y e l e c t r o n m ic ro sc o p y , o r a l com m unication-by Bars, P o n t e f r a c t end Cunningham, A n tig o r-ite I s a n o n -fib ro u s 'form o f th e same m in eral a s c h r y s o tile . By tran sm ission electro n m icroscopy. phemXL x.-.tssisrf? mwv.-.v. y 1!, st;.issn iiV t'-VViV.VLV prrr-s^rr .irftJLifr wati's '.v.ri'.i-.'U t*"TM t iW/-4usui riTzi;,' 'pyrrr.'M:i-%': Jsisi.ttiK'i ilitisar SftSlTiSSjw fntiTVtiZ. jCVss'vvss-i RtTHmiy :rrui-- f,~'VV.-.-^-.' jis7K4V;;WvSizi'rW; e^s-mss t'-litCWSi jriiriitsr *.,w -- ... f.Vv.SAV.ii LiW-r-.V' fcy.V.W-is'A pass HHS00000224 CPC-BCALTRSCPT00001167 TABLE IV liSTS?!!*;- AMPLE SO, 1 KEY TO SAMPLE NUMBERS OF COSMETIC TALCUM-TYPE POWDERS PRODUCT KAME AicmeRS Powderj, M ed icated FURTHER IDENTIFICATION .B ristol-M yers /No. IF25) r-;' 2 Amolin Deodorant Powder 3. Aquam arine C oaling S pray B ath Powder 4 B a g a te lle Amber D usting Powder 5 B ou rjois B ath Powder 6 Deletes ene M edicated Powder 7 Cashmere Bouquet Body Powder Norwich Revlon (143) Corand {DCR) Penrjwalt (5274) Colgate-Palm olive % pit: V.rv-iiMTiw i"5-,-?AVATa'-,w.v & Chanel No,, 5 B ath Powder 9 Countess Rocheau Cake D usting Powder 10 C repe Do C hine D usting Powder, M illo t n C repe Ete C hine Roudre 'M ist, M il l o t 12 C u tic u ra Talcum Powder 13 Desenex Jergetis \\ \ \ Bouse o f Fragrance (LI132) \ House o f Fragrance B ites. (07170) WTS-F h a rttta cra ft 14 Befritin, Baby powder P f i z e r (1:139-2) (3 /2 9 /7 2 ) 15 De-sitir , Baby Powder 16 Diapaxene Baby Powder F fi#*r ( USA) (5/10/72) Freon (E1030) 17 Dorothy Gray HS e c r et Of The Sea.*1 D usting powder 18 Saeraude. Talon, Powder Doty (355-4010) 19 E n glish Leather Mem 20 Faberge uM asic,r B usting Pow der (2891) 21 F r ie n d s h ip Garden D u stin g Powder- Stallton (3/27/72) 22 F rien d sh ip Garden Busting Powder Shu)ton <5/9/72> Zitkiin iartr.-.t.', SitMitSl 'Wirt-s ;Lk s v .*^- fcSS4ji iriiittti 23 F rie n d s h ip Gardes Dusting Powder Shelton {7/13/72} (-vt-vvr ^irr.V!' gs s-'-w .vtsv'f HHS00000225 CPC-BCALTRSCPT00001168 PLE 0, PRODUCT SAME 4 Heaven Sent A erosol Bath Powder M ist 5 Heaven S ent Bath Powder ; :6 H e le n P re ss'! k i t t l e 'Lady'1 17 I m p o r ts , S p ain Mens' T a lc U I s i s F l o r a l Talcum Powder 29 J o h n s o n 's Baby Powder 30 Johnson and Johnson M edicated Powder 31 Roe c o t 'Beauty D u st--O il o f Mink 32 L a n v in A rpege D u stin g powder 33 Lanvin Arpege Powdered M ist 34 Lanvin Arpege Talc 35 L ew is Baby Powder 36. Loves Fresh. Lemon 0 l o s s y Powder 3 7 ' Many' s S c e n te d B erated Talcum. 38 H s c y 'a Talcum , Apple: 39 H s r c e lle D ie tin g -Powder, Kype-~A lle r g e n ic 40 Mary Chess Perfusted B usting Powder 41 Meneen Baby Megic Powder 42 Mermen Quinsane F o o t powder 43 Merck T a lc , P ro d u c t HoT 6460, L o t No, 6460) 44 Meocsana 2387-B M edicated Powder 45 Old Sp ice Body Talcum 4ft P e r s ia n L ila c Deluxe D usting powder 47 P e rs ia n L ila c Spray Bath. Powder 48 Pond' s PerfuBied T a le Body D eodorant. Bream, Flow er 49 P r in c e M a tch a b o lli B eloved S p ray Powder FURTHER IDENTIFICATION R u b in stein R ubinstein (028Q) (3612) (1288) Mauley & James (2K4) <51123 (H2Q2) (SQ39301) Plough Snulton A p r i l Showers <LfN) A p r il Showers (B2QQB) <h s b ) rv.^nvrr.r\v.;rvrA^v,/^vx>i\vvhr^^wy.V;r;;';ii-VTrri:fF^^ rpws.vrti'"-'> ; S b v **a VA: ."^vv:;.""hV/i^Vtv.V-V,- a.!LVwiV5=.W,i si-sw?** s a w -w * * ri.5ftWiWft,w 'Ji-.iiAir.-ifTj KV-W.^-Atv '.Z'S.zztv.a 1v v u .'--,v'v.t rviwti-xt 'i-r.v/rA!i' ii'.Tienti; 'VSlitiPn ii ii.Vi,--d: HHS00000226 CPC-BCALTRSCPT00001169 M?LE yo, PRODUCT M UE 50 Q uest D eodorant Powder 51 R eplique Spray Bath Powder 52 Rxviana Poods - Italian Stearin Tale 53 Septem ber Mom By Pond' s 54 Seven Winds A f te r B eth T a lc 55 l! S P T a le 56 V a s e lin e I n te n s iv e C are Baby Powder 57 Iv es S a in t L aurent Rive Gauche S pray T a lc 58 Z B T Baby Powder 59 geaeorfa Super Absorbent M edicated powder 60 Ambush-Daua D usting Powder 61 A p r il Shower 62 Avoir U n f o r g e tta b le Perfum ed Talc 63 B eloved P e rfa iasd D u s tin g Pow der, P r in c e M atchabelli 64 Coty Face Powder Rachel 65 .D esert Flow er S pray B ath Powder 66 Bser&ude D usting Powder 67 Baeraude Spray Dusting Powder 6.8 F a b e rg e Flaiibe&u D eodorant S p ray Powder 69 J e a n K a te S pray B ath `Powder 70 J e r l s T a lc , F lesh 71 J o l l e Madame D u stin g Pow der, B alm ain 72 Lady E s th e r Face Pow der, R achel 73 Max F a c to r P ace Pow der, R a c h e lle 74 M e d ic a te d Com fort Powder 75 OH.' da London Talc. FURTHER IDENTIFICATION Bariums Raphael (004) For Rice (19B) DuBarry <021085} (I 209) (F102X) Stiefel (9684) nb.r r;vi U-Hi i#*Z4Tisr* iSti'Vii'-fen-is S h u lto ti (F 1 BKI) Coty Coty ( l AST) <37 W$F) ` (1 SJ 247) nv.rwa'AV^ ,r,nv,tl::.r mr.*:-'-' iSillU'i P ark e-D av is Vardley (498) b:5t::rst gs; Sir f::r: HHS00000227 CPC-BCALTRSCPT00001170 MPLE NO, FROmCT NAME 76 To Know Mo l e To Love Me - T in k e r b e ll 77 Touch And Glow F ace Pow der, Creamy P each ' 78 Toujours Moi Bath powder 79 Y ardley A p ril V io le ts 50 Cl-.cmti1ly Dusting powder 51 Cashmers Bouquet 82 J e a n Hafc^ T a lc S3 Heixnen Shave T a lc 84 Shower To Shower Body Powder 85 P u re Baby Pow der, D art Dreg S6 Pond1s Dream Flower PerftiroeS Talc 87 Almay Hypo-Al 1e r g e n ic F ace Powder 88 Constance C a rro ll, Bouquet Talc 89 D jar-K iss Talcum 90 Flam ingo D usting Powder, Tussy 91 L ander L ila c s And Boses T a lc 92 Mavis Talcum 93 Mavis Body Powder 94 Tangee 95 2BT Baby Powder 96 B la n c h ard 's D ueting Powder 9? Bom W ild T e stin g Powder 98 L ander' G a rd e n ia And Sw eet P ea T a lc 99 L ander L i l a c s And R oses D eodorant Body T a lc 100 M iss D ior D u stin g Powder 101 T a i Winds S p ra y T a lc FURTHER IDSKITXF1G4TI.DK Tom F ie ld s , Ltd, Revlon Garday (49QS) Houbigsnt (IIP) (on 345) (B 81) Johnson & Johnson (5507BG) (K 11C) (0 13 D) Kerkoff (1104?) Vivaudou Vivatidou Luft-X&ngee (B0Q48) Del Labs (Avon (DOC 1272 2 - 1 4 -7 2 ,W S) ^ ^r*l-lvt 1 'A HHS00000228 CPC-BCALTRSCPT00001171 4FLE SO, PRODUCT NAME 22 l o s e s D ueting, powder 03- C oty L'AUfiant Talcum powder 04 Cflty- Em.erau.de Talcum Powder 03 C oty L 1A im in t D ustin g Powder ,06 Coty Im prove m is tin g Powder ,0?" Cofcy Magnet ces Beds D u stin g Powder .08 R evlon I n tim a te Perfum ed Bath 'Powder (09 J e a n N&tdf feath Powder 110 Je a n N a t / Spray Bath Powder 11:1 Did S p ic e Body Talc 1X2' D r, S c h o l l ' s R oot Powder 113 Fab erg e Xanadu Luxury Bath Powder Spray 114 F aberge Z ia a n ie de F ragonard 115 F a b e rg e T ig r e s s Bath powder 116 F a b e rg e Woodhae f o r Men 117 F ab erg e B r u t f o r Mao. Shower Buff- A ll-O v e r Body Powder 118 FAberge l& te 119 F aberge A phrodesie B ath Powder 120 Fabe rg * Straw Hat Bath Powder 121 Faherge Aphrodesia fo r Ken Shower B uff 122 'F aberge Xanadu de Luxe B ath Powder 123 F a b e rg e Woodhue B ath Powder 124 F aberge Finite D usting Powder 125 F a b e rg e F lam in ae B ath Powder FPRTEER ID W TIFI CATION (UJ) -(01A) (IM> (2 D 0 ) (241) L anvin - Charles of the R ita (2137) Lanvin - Charles o f th e R ita {2103} Shu1 to n , in c , (MFC) <20517). (Yl) (2132)' R ef, 61159-0X9 Ref. 2052-003 Ref. 5027 (0252) Ref. 5400 (raw m a t e r i a l ; from.. F ra n c s) Ref.. 2052 <23,72 > R ef. 5027 Ref. 1244-028 (2342) Ref. 2052-002 Ref, 0714-018 (1121) R ef. 2052 (.3471) rijjT f-rjsurn CPC-BCALTRSCPT00001172 \MPLE .BSD* PRODUCT NAME 126 Hennen, Baby Magic 127 W a lg r e s a 's C rib Age 128 C a ld e se n e M edicated Powder 129 D a s lte a 130 V a se lin e I n te n s iv e Care 131 Johnson and Johnson M edicated Powder 132 Johns on Baby Powder 133 Johnson,* s Baby Powder 134 Johnson's Baby Powder 135 Johnson and Johnson Medicated Powder 136 Johnson and Johnson Shower to Shower Body Powder 137 Johnson and Johnson Shower t o Shower Body Powder 138 Johnson and Johnson Shower to Shower Body Powder 139 Avon Brocade Sjytay 140 Avon B ird o f P a ra d ise Spray 141 Avon Tax Winds S pray T alc 142 Mermen B ath T a lc 143 Pia-Zow T a lq u e 1 4 4 O v erto n 's ,1High~Browtin Pace- Powder 145 S o f t e e Face Pdwdar 146 W e s t p o r t Face Powder 147 H azel Bishop P ressed Powder 148 la d y Wayne Face Powder 149 S o l i t a i r e Cake Makeup 150 Dte&raglo- P ressed Powder FiETBEA id e n t if ic a t io n ."l^VVvVVUW gsr*i'j7 . iSwWWfflt-jfi-Jta ivuwjw:w,'y,'.- .S3.il; (lcSt) (109T) (G452K) <C 5122) (0709X1) (0872K) (31602) (B1652) (4065) (A 308) Perfection. Beauty Products, I n c * , P earl R iv e t7 N. Y. i!s,;V;-:V:;^?y:i:rt;j:-;. 'M?ff-r-vv%V4^ J fS X U 3itz7ir isvA.vw/r.w!-. UMitmsMi.s'i vuyvv-vv-.y.i-;. !S$y5>v*H'i3 vinuihK '.VtWit.'WviV ifra ifriT iC tr ;tr*?.rysv .r;!iSS5?i- TM-tiy-vJJ .>Z--V.1V A J-VWS!>i*$ KZJlf-iiii sj.yaW/vv iwsrriY."; ftlCr?.*:?/," te='i 'iririr str-srs?*? V pVS.V.-,*M arid--!1? HHS00000230 CPC-BCALTRSCPT00001173 iMPLE NO- PRODUCT mME LSI E a r ly American, Old S p ic e Talcum powder L52 Oars ag e Das t i n g Powder 153 Ammons Pow der, M ed icated 154 Bismolixic- M edicated Powder 155 R ite A id Pure ia b y Powder 156 i a m e r P u re Baby Powder 15? Mavis Im ported Talcum 158 Avon B rocade Perfum ed T a lc 159 Avon B lu e Lota Perfum ed T a lc 160 Avon B eau ty Bust R e f i l l - Charisma 161 Avon E lusive: Beauty Dust R e f ill 162 Avon Rdgence Perfum ed T a lc 163 Pinattd Clubman T alc 164 Grand U nion Baby Powder 165 Cashmere Bouquet 166 A lm y Pace. Powder, S o f t Beige 16? Tawny Tone Body T a lc Prom B lack H e rita g e 168 C o lg a te Tooth Powder 169 Dr- L y o n 's Tooth Powder 170. "C" B ouquet T0.lt:. 171 Tange. D u stin g Powder 172 J e r i s T a lc 173 C orsage O u stin g Powder174 L ander G ardenia A Sw eet Pea "D eodorant Body T a lc FURTHER- IDBfriFXCATIOM Lander rv-vt&vsv.vt;-. 'WFHzstfrtfw. iaiiiO'sai (101672) (4212DX) (S u p p lie d by M fg r.) .( L is t No. 7 1 9 , L o t 201, Supplied by Mfgr, ) (B eauty M ustus, Inc. G reenw ich, Conn,) . S: z: J-TZKi^Xm rv.c^ir.-s .irv.r'rLv.r ZsSTTlizit.;- V`.uLVn?tZs&w:* XAXfAx: (W inarick, Inc. D is tr . by F . W, Wool-worth) (2662) (G eorge 17. t o f t C o.) (2762) (W inariek) (2732) (Lender Co.) iisssifjir ,'A,v liVirzx C-siSiv.^r ji-vrs^/t HHS00000231 CPC-BCALTRSCPT00001174 AMPLE m, gR-ODr mm 175 L ender Baby Powder 176 la n d e r L ila c 4 Eases Body l a i c 177 Beloved Perfumed D usting Powder 178 J e a n H a t / T a lc No. 60 179 J e a n N at / S ^ ta y &a t h Powder 180 T in k er-bell Body T alc 181 Y ard ley S igh Shadow Brush-O n Eye Shadow 182 Max .F acto r Face. Powder, R ach el l e 1,83 Tweed, B a th Powder, L e a th e r ic 184 Y etdl ey N ext to. N atu re S heer P re s s e d Fowdar 185 Yard le y A p r i l P i o l e t s D u stin g Powder 1S6 Yardley Red Roses Dusting Powder 187 Y ardley S pringflow ers l a i c 188 Y ardley White. Lavender T a lc 189 Y ardley Red Roses T alc 190 A p ril Showers D eodorant T a lc 19 C h a n tilly H oablgant B usting Powder 192 T itik e rb e l 1 D usting powder .193 T i n k e r b s l l Powder M itt 194 Tim k-erbell D usting Powder 195 T in k e rb c il Body T a lc FURTHER IDEKI.IgIGfe.TIOH P r in c e M a te h a b e lli (235A) (2264) (2101) (TOi:i F i e l d s j L td , , Div. o f MM) Ref. No. 721 (S u p p lied by Mfgr. ) (Y ardley)(44) iV I-;:;-:::;:;. (260) (271) (214) R ef. No. 9882 (2JBB) (Tom F i e l d s , L td . ) (Tom F i e l d s , L t d . ) (Tom. F i e l d s , L td . ) (Tom, F i e l d s j L td . ) itiUiii noiiuM Ls*v."-v.- fMiUVt HHS00000232 CPC-BCALTRSCPT00001175