Document J7JxLddNGJmexE75BDnQw3je

FILE NAME: Colgate (COL) DATE: 1972 Aug 3 DOC#: COL006 DOCUMENT DESCRIPTION: Unpublished Internal Report for FDA RE Talc August 3, 19?2 Dr. A lfred W eissler, A cting D irector- D iv isio n of C o lo rs and C osm etics Technology O ffice of P ro d u ct Technology c Food and Drug A d m in istra tio n Departm ent of H e alth , E ducation and W elfare W ashington, D. C. 2020^ Dear Dr. W eissler . -- E n c lo se d p l e a s e f i n d my f i n a l a n a l y t i c a l r e s u l t s on th e m ineral com positions of 102 exam ples of stan d a rd , com m ercial products c o n tain in g ta lc . These Include a l l th e specim ens you s e n t me from W a sh in g to n , e x c e p t f o r a few ( p r i n c i p a l l y 35he pharm aceutical specim ens) w hich I w ill re p o rt on s e p a ra te ly , as w e ll a s a number- t h a t I p u rc h a s e d i n Hew York and i n B o s to n . The a n a ly s e s show t h a t 59 o f th e p ro d u c ts have no d e te c ta b le am ounts of any o f th e a sb e stifo rm m in erals (by th e tech n iq u e em ployed, p rp p o rtio n s by w eight of 1-2^ o r le s s could escap e d e t e c t i o n ) , 20 had sm a ll b u t d e f i n i t e p e rc e n ta g e s o f tr e s o llte , 7 had sm all p e rc en ta g e s of c h ry s o tile , 9 had sm all p e rc en ta g e s o f b o th tre m o lite and c h ry s o tile , and 7 had sub s ta n tia l percentages of one o r both of th ese asbestiform m in erals. ' I s h a ll r e ta in and p re se rv e the o rig in a l specim ens, and the x - r a y d i f f r a c t o g r a m s , u n t i l y o u a d v is e me o th e r w is e . With v e ry b e s t p e rso n a l re g a rd s , S in c e re ly y o u rs, Seymour n . newin P ro fesso r of Chemistry QE-CPC2-00000011 TABULATION OF X-RAY DIFFRACTION ANALYSES OF COMMERCIAL PRODUCTS CONTAINING _________________ TALO_____________________ A. P ro d u c ts having no d e te c ta b le amounts o f a s b e s tif o r a m in e ra ls { lim it o f d e ta c ta b ility = c a . 1 to 2$ f o r each m in eral) Product M ineral Com position T alc C h lo rite P h lo g o u ite o<-Quartz D olom ite O ther 1 70$ 3$ 2 100$ n .d . 3 99$ n ,d . 4 100$ n .d . 5 95% 2$ 6 80% 2$ 7 86% 7$ 8 95% 2$ 9 89$ 7$ 10 93$ 3i 11 90$ 2$ 12 130$ n .d . 13 60$ n .d . 14 - 31$ 50$ 15 100$ n .d . 16 17 60$ 30$ 18 90$ 4$ 19 97$ 1$ 20 35$ 6o$ 21 67$ 25$ 22 59$ 35$ 23 42$ 50$ 24 94$ 1$ 25 95$ 2$ 26 95$ 1$ 27 88$ n .d . 28 29 20$ 94$ 1O$cf 30 97$ 1$ 7$ n .d . 1/0 n .d . 3$ 5$ 2$ 3$ 2$ 2$ 2$ n .d . n .d . 2$ n.d . 4$ 2$ 2$ . 1$ 2$ ' 1$ 2$ 2$ 3$ 4$ 2$ n .d . 2$ 2$ . n .d . n .d . n .d * n .d . n .d . n .d . 3$ n .d . 2$ 2$ 4$ n.d* n .d . 10$ n .d . *** n .d . 2$ n .d . 4$ 3$ n .d . 3$ 3$ n*d. n .d . n .d . n .d . n*d. rud. n .d . n.d . n .d . n.d . n .d . n .d . 2% n .d . n .d . n .d . 2$ n .d . n .d . 7$ n .d . 6$ 2$ ' n .d . n .d . 3$ 5$ 3$ n .d . n .d . n .d . 19$ n .d . 2$ n.d* ZnO ZnUd ZnUd X.S CaCOjq QE-CPC2-00000012 Product 31 32 33 34 35 36 37 38 39 40 41 42 43 44 . 4 5 46 47 48 49 50 51 52 53 54 55 56 57 58 59 T ale w 80$ 55$ 78$ 78$ 79$ 38$ 87$ 94$ 66$ 81$ 89$ 6$ n .d . 65$ 48$ 100$ 88$ 100$ 95$ 100$ 85$ 90$ 90$ 78$ 86$ 79$ 96$ 90$ Ohio 50$" 7$ 40$ 7$ 4%$ 50$ 5$ 3$ 25$ 8$6$ n .d . n .d . 30$ 40$ n .d . 4$ n .d . 5$ n .d . 8$ ^$ 3$ 15$ 7$ 15$ n.d* n .d . c Papre 2 M ineral Com position P h lo ffo u ite c4-.uar~ 5T 3T 3$ ' 2$ 2$ n .d . 4$ 3$ 2$ 10$ 2$ 15$ 5$ n .d . 4$ 2$ n .d . 1$ 4$ 2$ 3$ 3$ 2$ n.d . 1$ n .d . 1$ n.d* n .d . 3$ n .d . n .d . 5$ n .d . 2$ n .d . n .d . 2$ n.d . n.d . n.d . n .d . 4$ 3$ 2$ 2$ 3$ n .d . 2$ 5$ 2$ 1$ n.d* 3$ n .d . 4$ n .d . 3$ D oloralte O ther 5$ n.d . n,d , n .d . n .d . n ,d . n.d , n .d , n .d . n .d . 2$ 5;% n .d . n.d . ' _ 2n0 X S QE-CPC2-00000013 B. Products having small amounts of f r a m o l i t s ' m o r e than 1$, . but n o t more than~T5^2}^ by w eight Product M ineral Composition T a lc C h lo r ite P h lo g o p ite cx'-Quarts D olom ite T rem olite 60 6 l$ 30$ n .d . n .d . 6l 35$ 40$ ' 2$ 3$ 62 89$ 2$ - vl$ 3$ 63 8?$ 2$ 2$ : nd 400$/ 64 84$ 5$ Jr* c 65 79$ 15$ n .d . n .d . 66 85$ 5$ 3$ n .d . 6? 75$ 15$ 1$ n .d . 68 78$ 15$ n .d . n.d* 69 96$ 1$ 1$ n .d . 70 26$ 60$ n.d* - 5$ 71 84$ 10$ n .d . 3$ 72 86$ 5$ 3$ 4$ 73 -7 9 $ 10$ 1$ 3$ 74 92$ n .d . n .d . n .d . 75 75$ 5$ 2$ n.d* 76 75$ n .d . 5$ 5$ 77 91$ n.d' 4$ 78 85$ 2$ 1$ 2$ h.d' . 79 86$ 5$ 4$ n .d . 7$ 2$ 18$ 2$ n .d . 5$ n .d . 5$ 3$ 3$ 4$ 2$ 2$ 5$ 5$ 4$ 5$ 2$ n .d . 2$ 7$ 2$ n .d . 3$ n .d . 2$ 5$ 2$ 5$ 3$ 15$ 3$ 10$ 5$ n .d . 3$ 3$ 5$ 2$ 3$ QE-CPC2-00000014 -.1 C P r o d u c ts h a v in g s n a i l am o u n ts o f C h ry s frc ile b u t n o t m ore th a n (5 * 2 )% b y w e ig h t. P ro d u ct M ineral C om position n?aic C h lo r ite P h logop lte o^-Quart? 80 w* b0% n*d. 81 803? 711f* . -- 1% 82 76% 12% 2% 83 81J6 6% 5% ei %7% k% 1$ ' 85 83$ 5% 2% . 86 82$ k% 9 ft n .d . n .d . n.d* n o r e tn a n 1%, D olom ite C h ry so tile n.( k% b% CfO ~w H 3% 5.% 2% Uf% k% QE-CPC2-00000015 D. Products having snail amounts of both Tremolite and Qhrysotile more than 1%, but not more than {5 2 )% of each by weight. Product M ineral Com position T alc C h lo rite P h lo g o o lte ^-Q uartz D olom ite Tremol i t e ChrysotJle 87 28% 50-g 88 61% n .d . 89 68% 1.% 90 55% n .d * 91 21% 1;% 92 6 ii n .d . 93 55% 1% 94 k% 95 87% n . d . n .d . n .d . JoPaf y% 3% 3% n.d* h% 12% h% OC/oof 5% 2 5% h% 5% 8% 10% 5% 5% 7% 2 5% 5% 5% 69% 3% h% 5% 6% 20% 5% 5% 6% 25% 5% k% 6% _ 35% M> 5% 5% k% 2% 2% QE-CPC2-00000016 j! fe, P roducts h avin g s u b s t a n t ia l amounts o f C h r y s o tile a n d /o r T B em olite -- more' th an '$'~2)% by w e ig h t . Product M ineral Com position Talo C h lo rite P h logon lte ot-Quarts Dolom ite T rem ollte C hrysotile 9976 6361%% n-o.fd . 31%;% 98 3 9% n .d . *5of 3% 99 37% J/> 3% 100 76% 7% k% 101 53% Q% 3% 102 65% n . d . n .d . 6% 7% OQs/t0f 10% 5% 35% 12% 15% ko% 6% 2% 10% bo% 6% 3% 8% n .d . 2% 32 6% 7% b% 25% n ,d , 3% 15% 10% 7% i i l Pd'je b QE-CPC2-00000017 t. Products havins TBeaolite -- more tnan 0 4 2 )* J Produci 96 97 98 99 100 101 102 Talo 66% 31% 39% 37j 16% 33% 65% Mi yifral Composltl.QK C h iom e phiosooite 1 1 n .d . nX/o nd. 3% 7$ 8% nd. x3%i 3% k% 3% nd ^sms^ 6% )/0 ho% nd 7% 3% msam 1% 35% 6% 62% k% 15% " a/" Zsrnsme. S i m s & i i t Ofi _ , n rd1 12J Z% 3% 32 2 5% 10% 10% Q y\ n f 1 5% 10% 8% 6% n.d 1% ? QE-CPC2-00000017 notes- to the tabulated data 1* , Products t e s t e d were standard and com m ercial b ra n d s, purcnased in drug sto r e s or the drug departments o f departm ent s t o r e s or su p er-m ark ets i n th e c i t i e s o f W ashington, D, C ., New York, and B oston, ' * - . i 2. d a ta a re b ased upon co n tin u o u s sca n x-ray oowder d if r a c c i n p a tte rn s. The p r e c is io n , in terms o f average d e v ia t i o n , i s ox vhe ord er o f m agnitude o f 2% a b s o lu t e f o r each . th e m ineral s p e c ie s r e p o r te d . The data are g iv e n in u n it s ' of''percentage com position by w eig h t. x., o f d e t e c t a b i l i t y by th e method employed a re order o f m agnitude o f 1 t o 2% by w e ig h t f o r each o f th e m ineral sp ecies c ite d , - - -- - 4 , A, Where an a s b e s t if c r m m in er a l was in d ic a t e d by th e x -r a y pattern a s b e in g p r e s e n t t o a d e f i n i t e l y d e t e c t a b le e x t e n t , i t s p r e se n c e v?as v e r i f i e d by th e u se o f o p t ic a l m icro s cony to d i s c lo s e tn e p resen ce o f s i g n i f i c a n t numbers o f f ib e r p a r t i c l e s , B. Where th e a s b e s tlfo r m m in era l was in d ic a t e d by th e x -r a y p a t t e n i aS b?i n s P r e se n t a t th e j u s t b a r e ly d e t e c t a b le l e v e l . \ t h i s sS3 v e r i f i e d (o r r e j e c t e d ) by enrol oyin g th e s t e p - s c a n t e c h nique over the region s o f the questionable d iffr a c tio n peaks. ' The f o llo w in g m in e r a ls w ere e stim a te d by com paring th e s m of the integrated in t e n s it ie s at the d iffr a c tio n angles ' l i s t e d _b e lo w , w ith th e c o r r e sp o n d in g summed in t e g r a t e d i n t e n s i t i e s au th e same a n g le s o f sta n d a rd s composed o f "the pure m ineral M neral Two-Theta V a lu e s ' Summed Dolom ite ^-Quartz C hlorite P h lo g o p its 3 1 0 -- 3 1 * 2 ; 4 4 .8 --4 j.G ; 2 0 .4 - 2 0 ,6 } 2 ,6 - 2 7 40 ;"'-3 9 .3 -3 9 .7 0. 3- 6 . 5 ; 12 . 4- 12. 8; 1 9 . 0 - 1 ? . 2.; 25. 0- 25,4 8 . 6 - 9 . O 2 5 .9 - 2 6 ,1 ; 2 8 . 1 - 2 8 . 3 ' X ^ , 6w Only two o f th e a sb e stlfo r m m in erals were d e te c te d i n fr.prf <3'uci;3 t e s t e d , Each o f t h e s e was e stim a te d by co m p a riso n if l t h sta n d a rd s made up b y a tix in g th e pure m in era l w it h cu r e t a l c I n v a rio u s p ro p o rtio n s by w e ig h t. For both unknowns and stan d ard s 15 e Eea2iared was th e r a t io o f th e in te g r a te d in t e n s it y mu a r e l at i ve to th a t of an in te r n a l stan d ard *' m e in t e r n a l stan d ard e n p lo y ed was 5% by w e ig h t o f ^ (0 B )C 1 * The in t e g r a te d i n t e n s i t i e s w ere summed a t th e f o ll o w i n g d i f f r a c t i o n 8TlXSa i ' ^ , A sb e stlfo r m Elneral C hrysotile T rem ol!t e >t Two-Theta V a lu es Summed 12,0 - 1 2 ,4 ; 2 4 ,3 -2 4 .8 1 0 .4 - 10. 6; 2 7 .4 -2 7 .6 , 2 9 .4 -2 9. 7 , 3 C .6 -j0 .9 i 33.2-33*4 - ft" n QE-CPC2-00000018 Talc was determ ined by d iffe r e n c e . The fo llo w in g a b b r e v ia tio n s are employeds n.d* * n ot d e te c ta b le 2>> 0 => s in e omide ZhUJ - s in e u n d e o y le n a te K ss Icaol i n S a starch Ca C0-, ~ Cairo, t e X = phase not id e n tifie d unim portant. because deemed I n s e v e r a l i n s t a n c e s , th e sa n e brand o f p ro d u ct wan pur chased in d iffe r e n t p la ces a t d iffe r e n t tin es* to check on th e constancy o f com position o f th e m ineral nizfcure. C onsiderable v a r ia t io n s were found. S e e p ro d u ct numbers and 15; 22* 22 smd 23J^ - l n >b th e r in s t a n c e s , c o n s ta n c y w ith in th e p r e c i s i o n o f th e a n a l y t i c a l method t-;as o b se rv e d ( e . g , , in th e c a s e o f n^od- u ct No, 7 ). * 9 QE-CPC2-00000019 KE]LTSLlS2SnSOM M Product Nnabar P rodu ct Name Further Identification 1 2 3 4 c w 3 8 $ 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 29 31 32 33 3% 35 36 37 $3 39 40 AMMENS POWDER, MEDICATED AMOLIN DEODORANT POWDER AQUAMARINE COOLING SPRAY BATH POWDER BAGATELLE AMBER DUSTING POWDER BOURJOIS BATH POWDER CALDESEME MEDICATED POWDER ------- CASHMERE BOUQUET BODY POWDER CHANEL HO. 5 BATH POWDER COUNTESS ROCHEAU CAKE DUSTING " . POWDER . CREPE DE CHINE DUSTING POWDER, MILLOT _ CREPE DE CHINE POUDRE MIST, MILLOT CUT! CURA TALCUM POWDER DESENEX : DESITIN BABI POWDER DESITIN BABY POWDER DIAPARENE BABY POWDER ; DOROTHY GRAY SECRET OF THE SEA DUSTING POWDER - EMERAUPE TALCUM POWDER ENGLISH LEATHER FABEBGE A'j^ffiIC" DUSTING POWDER i FRIENDSHIP GARDEN DUSTING POWDER ; FRIENDSHIP GARDEN DUSTING POWDER' * FRIENDSHIP GARDEN DUSTING POWDER . HEAVEN SENT AEROSOL BATH POWDER MIST HEAVEN SENT BATH POWDER HELEN PRES3L LITTLE LADY" ; INPORTA, SPAIN MENS* TALC ; ISIS FLORAL TALCUMPOWDER i JOHNSON3 BABY POWDER ! JOHNSON AND JOHNSON MEDICATED- | POWDER * KOSCOT BEAUTY DUST-- OIL OF HIM ; LANVIN ARPSC-E DUSTING POWDER f LANVIN ARPEGE ROWDERED MIST f LANVIN ARPEGE TALC f LEWIS BABY POWDER ' I LOVES FRESH LEMON GLOSSY POWDER l MACY*S SCENTED BORATED TALCUM I MACI`S TALCUM, APPLE I HARCELLE DUSTING POWDER, HYPO- f ALLERGENIC ' MARY CHESS PERFUMED DUSTING POWDER , 'B ristol-M yers {No, IF25) Norwich Revlon (143) Corand (DCH) Pennwalt ( 5274) JSolsgte-Palm ol1V J ergens House o f Fragrance (L1132' House o f Fragrance Pures: (0?1?0) WTS-Pharmao r a f t P fiz e r (1139Z) (3 /2 9 /7 2 ) P fiz e r {115A) {5 /1 0 /7 2 ) Breon (ElQiJQ) Coty {355-4010} Men (2891) Shulton (3 /2 7 /7 2 ) Shulton (5 /9 /7 2 ) Shulton (7 /1 3 /7 2 ) R ubinstein R ubinstein {028Q) (3612) (1288) Manley & James (2K4) QE-CPC2-00000020 41 42 43 44 45 46 4? 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 TO 71 72 73 $ 75 76 77 78 -79 ,,Hiraber Product Name Fiuthr Identificati on H.-JEH?NEN BABY MAGIC POWDER HENNEN QUINSANA POOP POWDER KERCH TALC, PRODUCT HO. 6 4 6 0 . LOT , NO. 6460) HEXSANA 2387-D MEDICATED POWDER OLD SPICE BODY TALCUM PERSIAN LILAC DELUXE DUSTING f POWDER PERSIAN LILAC SPRAY BATH POWDER POND' S PERFUMED TALC BODY (B112) (H202) (8039301) Plough S h u lto n < A p r il Show ers <LFN) A p ril Show ers (B200B) DEODORANT DREAM FLOWER PRINCE HATCHABELLI BELOVED SPREY i POWDER (115B) QUEST DEODORANT POWDER MEPLIQUE SPRAY BATH POWDER Parfums Raphael (004) RIVIAHA FOODS - ITALIAN STEARIN TALC F or R i c e SEPTEMBER KORN BY POND'S ' . ' (19B) SEVEN WINDS AFTER BATH TALC U S ? TALC DuBarrv ry (021035) 7ASELINE INTENSIVE CARE BABY POWDER TUES SAINT LAURENT RIVE GAUCHE SPRAY TALC Z B T BABY POWDER ZEASORB SUPER ABSORBENT MEDICATED POWDER ( I 209) (81021) S tiefel AMBUSH-DANA DUSTING POWDER APRIL- SHOWERS AVON UNFORGETTABLE PERFUMED TALC (9884) 5 ^ 2 '^ DUSTING POWDER, PRINCE HATCHABELLI COTi PACE POWDER RACHEL DESERT FLOWER SPRAY BATH POWDER EKEEAUDE DUSTING POWDER S h u lto n Co'ty * (F 1 SKI) EMERAUDE SPRAY DUSTING POWDER Coty FA3ERGE FLAMBEAU DEODORANT SPRAY POWDER EAH NATE SPRAY BATH POWDER ' ' JERIS TALC, FLESH ' (1 AEY) (3 7 WB?) (1 N 24?) 40LIE MADAME DUSTING POWDER, BALMAIN ' LADY ESTHER FACE POWDER, RACHEL " ?1AX FACTOR FACE-POWDER, EACHELLE ' MEDICATED COMFORT POWDER OH1 d e LONDON TALC Parke-D avis iS d ley V oQ ) TO KNOW ME IS TO LOVE ME - TINKERSELL Tom F i e l d s r td GL0S iC S PWDBH, OEEAM PEAC Toujours s o i bath poudeb 2AEDLSY APRIL VIOLETS . BctI ot' " otS p S (4908) 80 CHANTILLY DUSTING POWDER Houbigant OASHMERE BOUQUET_________ 82 JE M NATE TALC 83 HENNEN SHAVE TALC . 84 SHOWER TO SHOWER BG'DY POWDER ' rv (S 81) , J ohnson & J o h n so n ( 5507BG) 85 6 PURE BABY POWDER, DART DRUG *' (K lie) 8 ROND'S-DREAM FLOWER PERFUMED TALC (0 13D) A 1 - '' 1 Pa^e 10 QE-CPC2-00000021 Product Humber 87 88 89 90 91 92, 93 94 95 Product WamA Further Identification nxjr'U-ALLEJIGEtilC FACS POWDER CAPJiOLL, BOUQUET TALC DJER-EISS TALCUM flamingo DUSTING POWDER, TUSSY LENDER LILACS ADD ROSES TALC RAVES TALCUM MAVIS BODY POWDER TAJJGEE o ZBT BABY POWDER K erkoff (L104?) VIvaudou VIvaudou LuTt-Tangee (B0048) 96 ELANCEARD*S DUSTxNG powder 97 BOBU WILD DUSTING POWDER ` 98 labder gardeijia and sweet1 pea talc Del Labs 99 100 .Kal-S DIOR AND DUSTING ROSES DEODORANT POWDER BO] Y TALC 101 TAI WINDS SPRAY TALC " (Avon (DCC 1272 102 TOSCA DUSTING POWDER 2 - 1 4 - 7 2 , HWS) Psa ? Ii QE-CPC2-00000022