Document MGy0OqYyg4w1zoaKZeOLRzm2a

FILE NAME: Talc (TALC) DATE: 1972 Aug 3 DOC#: TALC150 DOCUMENT DESCRIPTION: Report for FDA - Analysis of Products Containing Talc with Cover Letter August 3* 1972 Ut Alfred Wsissler, Acting Director- Division of Colors and Cosmetics Technology Office of Product Technology Food and Drug Administration Department of Health, Education and Welfare Washington, D* C. 2020^ . Dear Dr. Weissleri _ - -- Enclosed please f 0f frSKMSinin^ ^ sent me from Washington, --cep* f -1]L1freTJ^.t on separately, as pharmaceutical in Hew York and in Boston, well as a number- uhau I purcnassa j.-* The analyses show that 59 of the (by the detectable amounts of any of th ,+ of -\^% or less could technique employed, proportions b y V e n t a g e s of aseaoe detection) , 20 had smajl ^ 9 hld small treaolite, 7 had small percentages oA ^nr/ootii , ? sub_ percentages of both tremolite an c ^ tiforiQ minerals, stantiai percentages of one or bouh of -hese aso,,* - J1 ssnhaailll rreettaaiinn aaunud. preserve t--he original ^eclaens, and the c-ray diffra_crtmo+-g.riTamvs,ouuandtviilseyomue aod^vnie.s.ewimse. With very best personal regards, Sincerely yours, ^ fy v -' Seymour'' Z. Lewis. Professor of Chemistry QE-CPC2-00000011 TABULATION OP X-RAY DIFFRACTION ANALYSES OF COMMERCIAL PRODUCTS CONTAINING T A L O ___________________ A Products haring no detectable amounts of asbestifora mineral; (limit of detactability=ca. 1 to 2% for each mineral) Product 1 2 3 4 5 6 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Mineral Composition Talc Chlorite 70% 100^ 99% 100% 8950%% 95% &9% 93% 90% 120% 60% 31% 100% <-- 60% 90% 97% 35% 67% 59% k2% 99% 95% 95% 88% 20% 99% 97% 3% n.d. n.d* n.d. 2% 2% not 2% 7% 3% 2% n.d. ru cL 50% n.d* -- 30% b% 1% 6.0% 25% 35% 50% 1% 1% n.d* 1% 2% 1% Phlogouite 7 % n.d. 1,% n.d. 35% _2l-------3% 2% 2;% 2% n.d. n.d. 2% nd. 9% 22% 1% 2% 1% 2% 2% 3% k% 2% zrd* 2% 2% cK-Quartz Doloaite Other n.d. n.d. n*d. n.d. n.d. n.d. 84 n.d. 2% 2% 9% n.d* n.d. 10% n.d. n.d. 2% n*cL K% 3% n.d. 3% 3% ' n*d. * n.d. n.d. n*.cL n*d. XI d.* n.d. n.d. n.d. n.d. n.d. n.d. __2$_______ n.d. n.d. n.d. 2% n.d. n.d. . 7% n.d. __ 6% 2% \ n.d* n.d. 3% 5% 3% n*d* n.d. n.d. 19% n.d. 2% . nd. 2n0 ZnUd ZnUd K,S C'aCO-j X QE-CPC2-00000012 Prodpot 31 32 33 34 35 3 37 38 39 40 41 42 43 44 . 45 46 47 48 49 50 51 52 53 54 II 57 58 59 ii . Talo Wff 55% n% 78% 79% y&% 87% 945 66% 81% '8S6 % n.d* 65% 485 10G% 88% 100^ 955 100J 855 905 905 785 86% 19% 96% 90% Papre Chlorita 7 4o5 1% 5% 45 3%^ 25% 8% 6% n.d* rd. 305 405 n.d. 45 n.d. 5% n.d. 8% y%,, 155 1% 15% n.d* n.d. Mineral Composition Phlogonlte o4-Quartz . y% 3% 2% 2% n.d. k% 35 2% 2% 5% k% n.d. 1% 45 2 1% n.d, 105 15% n.d. 2;% 3% 3% 2% < n.d. - 35 n.d, 1% n.d* n.d, 2% n.d, n.d. nd* Dfi n.d. 2% n.d. n.d, n.d. n.d* 45 2% 3% 2% 2% 1% n.d 3% 2% n.d. 5% 3% n,d ' 45 n.d, 3% Dolonlte 85 8% 3% 8% 5% 7 .1,d. 1% 2% n.d, 5% 5% 3% n.d. n.d. k% 7% n.d. 45 nd* n.d. n.d, n.d. 25 45 n.d* 25 5% n.d. n.d. Other ' ' _ ZnO, X ' . 3 QE-CPC2-00000013 S . Trod nets "haring'small;"aao'orrts" ofJfrsinollte- -- more "than 1%% "but not more than {5^)% ^ Product Talc Chlorite jfj.ners.1 Composition Phloaiopite ^-Quartz Dolomite 60 61% 30% n.d. 61 62 35% 89% bQ% 2% 2% ,1% 63 8?% 2% 2%.. 64 8b% 5% 65 79% 15% nJr.*d. 66 85% 35 67 75% 15S i% 68 18% 15* n.d. 69 70 98% 26% 16*g,% 1% n.d. 71 8b% 10% n.d. 72 8b% 5% 3% 13 -7992%% 10% n.d. 1% n. d. 74 75 75% DP 2% 76 75% n.d. 77 91% n.d. 5:% b% 7789 8856%% 25%i J% n.d. 3% 3% bnL%>c/fo n.d. n.d. n.d. n.d. n.d. St b% 3% n.d. n.d. 5% 2% b% n.d. 7% n.d. n.d. 3% b% 2% 5% 5% n.d. 1% n.d, n.d, 5% 5% 15% 10% n.d, 3% 2% Tremolite 2\% 2% 5;% 5% 3% 2% 5% b% 2% %2;% 2 23,%% H3% 3% 5% 3% 5% 3% o . . ~y QE-CPC2-00000014 o . Products arlns b n t not more than {5^)/ -- c f C hryattlle . Product gale Chlorite Mineral Composition Phloj af-Quartz 80 k8% ko% n.d "1 81 __2$_______ 1* 82 76% 12% 2% 83 81% 6% 8^ 87% k% %2% , 85 83% 5% 86 82% %% 2% 8 4 ______ n.d. n.d. n. d. 4 aore than 1% T)olotalte Chrysotlle n.d. b% b% 2% ~W b% 38S% 5% 2% m, QE-CPC2-00000015 D. Products having small amounts of both Tremolite and Ghrysotile -*more than l%t but not more than {5 *2 )% f each by weight. Product Mineral Composition Talc Chlorite Phlogonite ^-Quartz Dolomite Tremolite Chrysotdle 87 ZQ% 50% 88 6l% n.d. 89 63% 1% 90 55% n.d. 91 23^ 1# 92 6i n.d. 93 55# 1% $k 43* 95 87# n.d. nd. n.d. ncf Jr3 y% 3% 4# 3% n.d* k% 12% k-% 5% 25% 4# 8% 10% 5% 7% 25% 5% 69% 3:% 4# 6% 20% 5% 6% 25% 5% 6% _ 35% 4# 5% \% 2% n,cpf 5% 5% 5% . 5% 5% It 5% 2% QE-CPC2-00000016 s s ^ P ro d u ow Talo 96 66% 97 31% 98 39% 99 37% ICO 76% 101 53% 102 65% ' C hlorlto n.-i. 1% nd* 3%. V nd u n i r a i Composition ,w iA r*i-o m o 2 B *=3S21. 2 S li 31$% 3:% 3% ht 3% 52 d 6% 7% 5%^ 35% ko% 6;% nd 2;% 7% k% 3% 15% T ra m o n ta C h ry so tiljL S S S 2 = ------------ *---------- OQrtffi 10% 12% 15% 2% 10% 3.% 3* 25% 10% 0* 6% n., 1% Pa-AS & QE-CPC2-00000017 KOBES-TO" JBB T A B O M T E D BATA""' All products tested were standard and commercial brands, purchased in drug stores or the drug departments of department stores or super-markets in the cities of Washington, D. C,, New York# and Boston, . / - All data are based upon continuous scan x-ra.y powder diffraction patterns, The precision, in _tera3 of average devia tion, is of the order of magnitude of x2% absolute for each of _ the mineral species reported. The data are given in units of per ' centage composition by weight. The limits of detectability by the method employed are of the order of magnitude of 1 to 2% by weight for each of the mineral species cited, - -- ' A* Where an asbestiferm mineral was indicated by the x-ray -pattern as being present to a definitely detectable extent, its presence was verified by the use of optical microscopy to dis close the presence of significant numbers of fiber particles, B Where the asbestiform mineral was indicated by-the x-ray pattern as being present at the just barely detectable level, \ this was verified (or rejected) by employing the step-scan tech- . niaue over the regions of the questionable diffraction peaks. The following minerals were estimated by comparing the sum of the integrated intensities at the diffraction angles listed below, with the corresponding summed integrated intensi ties at the same angles of standards composed of the pure mineral Mineral Two-Theta Values Suwmad Dolomite ^-Quarts Gilorite Fhlogopita 31.0 - 31.2 } 44.8-45,0.; . 20.4- - 20,6} 26,6-27,0;"'-3-9.3-39.7i 6,3-6,5} 12.4-12.8 19*0-19.2.k 25.0-25.4 8.6-9.0 } 25.9-26.1 ; 23,1-28.3t Only two of the asbestiform minerals were detected in the products tested. Each of these was estimated by comparison, with standards made up by Joining the pure mineral .with pure talc I n various proportions by weight. For both unknowns and standards, the parameter measured was the ratio of the integrated intensity of a diffraction peak, relative to that of an internal standard. His internal standard employed was 5% by weight of % n (OH)Cl, The integrated intensities were summed at the following diffraction angles.* ; o, Asbestiform Mineral . Two--Theta. Values Summed Chrysotile Tremolite i - - . 1f 12.0 - 12.4; 24.3-24.8 1 0 . 4 - 10,6 } 27,4-27,6 } 29,4-29,7 } 30.6-30,9 33.2-33.4 . fd*.? H QE-CPC2-00000018 Talc was determined by difference. The following abbreviations are employedi n.d* * Z.h 0 - Zn UJ - K e 5 = CaCOi = X = not detectable sine oxide sine undecylenate Kaolin starch cal cite phase not identified unimportant. because , . aeemed In several instances, the same brand of product was pur chased in different places at different tines, xo check on the constancy of ccrroosltion of the mineral nireure. Considerable variations,were found. See product numbers 14 and 15; 22, 22 and 2 3 5?"irP&ther instances, constancy within the precision 01 the analytical method fas observed (e.g*, in the case of prod uct Ho, .?) Pa^-s 9 QE-CPC2-00000019 Product 19naber 1 . 2. ; 3 ' 4 - 28 10 11 12 13 1165 17 18 19 20 21 22 23 2k 25 26 29 31 32 33' il 35 36 37 $3 39 ko .......KEY TO PRODUCT NAMES Product Name Further Identification M E N S POWDER, MEDICATED AMOLIN DEODORANT POWDER 'Bristol-Myers {No. IF25) Norwich , AQUAMARINE COOLING SPRAY BATH POWDER BAGATELLE AMBER DUSTING POWDER Revlon (l`i-3) Corand (DCS) BOURJOISBATS POWDER CALDESENE MEDICATED POWDER OARKWKRE BOUQUET BODY PQWPE2-- Pennwalt (527^) Colgate-Palmollv CHANEL NO. 5 BATH POWDER COUNTESS ROCEEAU CAKE DUSTING . POWDER CREPE DE CHINE DUSTING POWDfiR, MILLOT - CREPE DE CHINE POUDRE MIST, MILLOT CUT!CURA TALCUM POWDER DESENEX DESITIN BfffiY POWDER BESITIN BABY POWDER DIAPABBNE BABY POWDER DOROTHY GRAY MSECRET OF THE S&A" Jergens House of Fragrance (L1132 House of Fragrance Pures {07170} WTS-Pharmacraft Pfizer {11392) (3/29/72; Pfizer (115A) (5/10/72) Breon (B1Q0O) DUSTING POWDER ' EMERAUDS TALCUM POWDER ENGLISH LEATHER FABERGE DUSTING POWniR FRIENDSHIP GARDEN DUSTING POWDER FRIENDSHIP GARDEN DUSTING POWDER FRIENDSHIP GARDEN DUSTlNC- POWDER Coty (355-^010) Mem (2891) Shulton (3/27/72) Shulton (5/9/72) Shulton (7 /1 3 /7 2 } HEAVEN SENT AEROSOL BATH POWDER MIST HEAVEN SENT BATH POWDER Rubinstein Rubinstein HELEN PEESSL MLITTLE LADY" . IMPGRTA, SPAIN MENS* TALC ISIS FLORAL TALCUMPOWDER JOHNSON3 BABY POWDER JOHNSON AND -JOHNSON MEDICATED (028Q) (3612) P0WDER KOSCOT BEAUTY DUST-- OIL OF INK LANVIN ARPEC-E DUSTING POWDER LANVIN ARPEGE ROWDERED MIST LANVIN ASPEC-E TALC . LEWIS BA3Y POWDER LOVES FRESH LEMON GLOSSY POWDER MACY5S SCENTED BOBATED TALCUM MACY*S TALCUM, APPLE MAECELLE DUSTING POWDER, HYPO- , ALLERGENIC _ MARY CHESS PERFUMED DUSTING (1288) Hanley & James (2K^) POWDER' , ' QE-CPC2-00000020 -Procrg t Huaber 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 Product Name Purthgj Identlfioatlou HEHNEN BABY MAGIC POWDER KEHHEN QUINSANA FOOT POWDER (B112) (H202) MERCK TALC PRODUCT NO. 6460, LOT ! NO, 6460) (8039301) MEXSANA 2387-D MEDICATED POWDER Plough OLD SPICE BODY TALCUM PERSIAN LILAC DELUXE DUSTING Shxilton < : POWDER April Showers (LFN) PERSIAN LILAC SPRAY BATH POWDER April Showers (B200B) PONDES PERFUMED TALC BODY DEODORANT DREAM FLOWER (115B) PRINCE HATCHABELLI BELOVED SPRAY - POWDER QUEST DEODORANT POWDER , BEPLIQuE SPRAY BATH POWDER Parfuns Raphael (004) RIVIANA FOODS - ITALIAN STEARIN TALC ' For Rice SEPTEMBER HORN BY POND'S (19B) SEVEN WINDS AFTER BATH TALC DuBarry (021035) u s ? talc 7SELINE INTENSIVE CARE BABY POWDER (I 209) IVES SAINT LAURENT RIVE GAUCHE SPRAY TALC Z B T BABY POWDER (Si021) ZEASORB SUPER ABSORBENT MEDICATED POWDER Stiefel 60 AH3USH-DANA DUSTING POWDER 61 APRIL-SHOWERS 62 AVON UNFORGETTABLE PERFUMED TALC (9884) . 63 BELOVED PERFUSED DUSTING POWDER, PRINCE HATCHABELLI 64 COTY FACE POWDER RACHEL 65 DESERT FLOWER SPRAY BATH POWDER Shulton (P 1 3X1) 66 EHERAUDE DUSTING POWDER Coty 67 EMERAUDS SPRAY DUSTING POWDER Coty (1 AEY) 68 FA3ERGE FLAMBEAU DEODORANT SPRAY POWDER (37 WB?) 69 JEAN NATE SPRAY BATH POWDER (1 N 247) 73 JEEIS TALC, FLESH . 71 JfiLIE MADAME DUSTING POWDER, BALMAIN 72. LADY ESTHER FACE POWDER, RACHEL ' ' ' 73 liAX FACTOR FACE -POWDER, RACHELLE ' MEDICATED COMFORT POWDER. . Parl-ce-Davi 3 75 QE1 de LONDON TALC 'Yardley (493) 76 TO KNOW ME IS TO LOVE ME - TIMXERBELL fom Fields, ;,td, 77 TOUCH a n d GLOW PACE POWDER, CREAMY PEACH Revlon 78 TOUJOOH3 KOI BATH POWDER Cordsy -79 YARDLEY APHIL VIOLETS : . (4908) 80 CHANTILLY DUSTING POWDER Houbigant Si. CASHMERE BOUQUET________ 82 JEAN NATE TALC i 83 HENNEN SHAVE TALC (3 81) 84 SHOWER'TO SHOWER BS'DY POWDER ' Johnson & Johnson T550?3G) 35 PUBS BABY POWDER, DABX DRUG . V (S.llfi) 86 POND *S DREAM FLOWER PERFUMED TALC . (0 13D) A T I QE-CPC2-00000021 Product Number 87 88 89 90 91 92, 93 94 95 Product Name TP-n-r-hhe-r Identification ftT.WAY HYPO-ALLERGENIC FACS POWDER CONSTANCE CARROLL, BOUQUET TALC DJEE-KISS TALCUM FLAMINGO DUSTING POWDER, TUSSY LANDED LILACS AID HOSES TALC m m t f TALCUM MAVIS BODY POWDER TANGEE 0 ZBT BABY PONDER Kerkoff (L104?) Vlvaudou Vlvaudou Luft-Tangee (B0048) 96 BLANCHARD'S DUSTING POLDER Del Labs 97 BORN WILD DUSTING POWDER 98 LANDER GARDENIA AID SWEET PSA TALC LANDER LILACS AID SOSES DEODORANT BODY TALC 99 KISS DIOR DUSTING POWDER (Avon (DCC 100 101 TAT WINDS SPRAY TALC 2-14-72, 102 TOSCA DUSTING POWDER H M Pa** II QE-CPC2-00000022