Document 6wG3e1MagxMK5jmRyB7aZdMJE

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 Dr. Alfred Weissler Acting DirectorDivision of Colors and Cosmetics Technology c Office of Product Technology Food and Drug Administration Department of Health Education Washington D. C. 20204 and Welfare Dear Dr. Weissler , final analytical results on the Enclosed please foifnd10m2y examples of standard commercial you mineral compositions containing talc These include all the specimens products from Washington except for a few principally the sent me will report on separately as pharmaceutical specimens which I in New York and in Boston well as a number that I purchased show that 59 of the products have no The analyses of the asbestiform minerals by the detectable amounts of any by weight of 1-2 or less could technique employed proportions but definite percentages of escape detection 20 had small of chrysotile 9 had small tremolite 7 had small percentages and 7 had sub- percentages of both tremolite and chrysotile asbestiform minerals stantial percentages of one or both of these I shall retain and preserve the original specimens ray diffractograms until you advise me otherwise and the With very best personal regards Sincerely yours 1.3.2 1.3.2 . 1.3.2 SeymouZr. Lewin Professor of Chemistry CPC2-00000011 TABULATION OF RAY DIFFRACTION ANALYSES OF COMMERCIAL PRODUCTS CONTAINING TALC A. Products having no detectable amounts of asbestiform minerals limit of detectability 1 to % for each mineral Product Talc Mineral Composition Chlorite Phlogopite Quartz Dolomite Other HN 100 n.d. n.d. MIKO 100 n.d. n.d. MIKO 95 % % MIKO 80 % Hm52MNNN 86 NAEMNA N80-22020 N80-22020 95 NAEMNA Hm52MNNN Hm52MNNN N80-22020 89 78 Hm52MNNN N800-2222020 93 NAEMNA Hm52MNNN N800-2222020 90 NAEMNA % N800-2222020 100 n.d. n.d. N800-2222020 31 50 % n.d. n.d. n.d. A.d. n.d. "/ " "/ " " n.d. 10 n.d. n.d. n.d. n.d. % n.d. n.d. n.d. % n.d. % Znud N800-2222020 60 30 18 90 % " IJN21272N372 n.d. ANAMAM % % 20 35 60 21 679 25 22 "/ " 3" 5 23 "/ " 50 IJN21272N372 IJN21272N372 "/ " "/ " ANAMAM %- n.d. ANAMAM n.d. 3 % % 2.5 95 % " n.d. n.d. 26 955 1 IJN21272N372 n.d. n.d. 27 88 n.d. "/ " n.d. 19 29 94 2% "/ " n.d. % Ci: CPC2-00000012 Talo Chlorite 47 50 80 " " " 55 40 78 ! 78 2252ona 79 2252ona 38 50 87 94 "" 66 " 81 89 89 % 96 n.d. n.d. nid 65 48 100 88 100 .95 100 30 40 n.d. % n.d. % n.d. 90 90 78 86 % % 15 % 96 n.d. Mineral Composition Phlogopite Quartz 3232 3232 3232 3232 3232 " S% ae n.d. " te bebe "" " % % n.d. naa 10 15 n.d. made % her her n.d. % _ n.d. n.d. % n.d. n.d. % n.d. n.d. 2 % n.d. n.d. n.d. n.d. n.d. n.d. " " " " "fi % n.d. % n.d. % % 4E Dolomite % % 3 89 % 7a.d. % % n.d. 5 By % n.d. n.d. 4 % n.d. % D.d. n.d. n.d. % ANJAN n.d. % n.d. Other ZnO K CPC2-00000013 B. Products having small amounts of Tremolit~emore but not more than % by weight than % Product Mineral Composition Talc Chlorite Phlogopite Phlogopite Quartz = 60 61 30 61 35 40 n.d. 25 62 89 #HUHQHHHUNUNN 18 63 87 #HUHQH HUNUN 720AMA n.d. % ",, ",, HNMI020 84 #HUHQH HUNUN 65 79 15 66 85 #HUHQH HUNUN 67 75 #HUHQHHHUNUNN 68 78 #HUHQHHHUNUNN 69 96 #HUHQHHHUNUNN 70 26 60 71 84 10 72 86 % 73 -79 10 74 92 n.d. 75 75 % 720AMA c n.d. 720AMA , 720AMA n.d. SAA n.d. n.d. KHE FOHEN FOHEN d " " " n.d. n.d. n.d. n.d. n.d. INT INT "" " 3 n.d. n.d. 77 915 n.d. 78 85 DR 79 86 "/ " " NIHI ",, " " 2% % n.d. Dolomite Tremolite % 18 n.d. n.d. JEUUNEWS JEUUNEWS JEUUNEWS JEUUNEWS % n.d. JEUUNEWS n.d. n.d. % % 15 "/ " " " "/ " 2255ma " "/ " int2223 "/ " int2223 int2223 int2223 " " " ammymum ammymum "/ n.d. FMN FMN ammymum "/ " D. 3 CPC2-00000014 of Chrysttile -- more than 1 . C. Products having t shman all amounts but not more than 512 by weight Product Talc 80 48 81 80 82 76 83 81 84 87 85 83 86 82 Mineral Composition ; Chlorite Phlogopite Quartz 4.0 n.d. 78 Fbers 12 Fbers balde Fbers OT SL AL 8 IS 9 5% 62 45 n.d. n.d. n.d. % Dolomite Chrysotile n.d. , , , Mot Mot Mot 4234527 4234527 4234527 4234527 "/ "fi 4234527 4234527 CPC2-00000015 oD. Products having small amounts of both Tremolite and Chrysotile == more than % but not more than 2 of each by weight Product Mineral Composition Talc Chlorite Phlogopite Quartz Dolomite Tremolite Chrysotile 87 28 50 88 61 n.d. 89 68 13 90 5215 % n.d. 91 23 % 92 61 n.d. 93 55 be 94 43 % 95 879 n.d. n.d. n.d. % ",, "/ " " ", " " "/ " n.d. 39dKIL 12 39dKIL 25 39dKIL 10 39dKIL 2505BROininite 60 2505BROininite 261665 20 261665 25 261665 ses 2505B25R05BOROiininniteinite " "/ " "/ " " "/ "fi "/ " " "/ " " "/ 77557NNIN " " " "/ "fi fnnnnUn "/ " fnnnnUn fnnnnUn "/ " fnnnnUn un un CPC2-00000016 amounts of Chrysotile and E. TRPermoodluicttse h-a~vimnogre sutbhsan tan5 ti1al2 by weight Product Talc 96 97 98 99 100 101 102 66 31 39 37 78 53 659 Mineral Composition Chlorite Phlogopite n.d. % n.d. " % % n.d. "/ " "/ "fi "/ "fi " " ",, "fi " 3" n.d. Quartz % % 40 40 n.d. % % Dolomite " 35 ",, " " " "fl "/ " 15 Tremolite Tremolite % 12 % % % 25 10 Chrysotile 10 15 10 % % n.d. 7 * pen 9 we r perulimntabes sun aey wr t * CPC2-00000017 NOTES TO THE TABULADTAETD A 1 All products tested were standard and commercial brands purchased in drug stores or the drug departments of department stores or markets in the cities of Washington D. C. New York and Boston - i 2 All data are based upon continuous scan ray powder precision diffraction patterns tion is of the order The of magnitude in terms of average devia- of % absolute for each of the mineral species reported The data are given in units of per- ' centage composition by weight detectability 3 The limits of 2 by of the order of magnitude of 1 to mineral species cited.. by the method employed weight for each of are the asbestiform 4 A. Where an asbestiform mineral was indicated by the 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. pattern Where the asbestiform mineral was indicated the ray as being present at the just barely detectable level *. this was verified or rejected by employing the step tech- nique over the regions of the questionable diffraction peaks 5 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 ; Theta Values Summed Dolomite Quartz Chlorite Phlogopite 31.0 - 31.2 44.8-45.0 20.4 - 20.6 39.3-39.71 6.3-6.5 12.4-12.8 19.0-19.2 19.0-19.2 25.0-25.4 8.6-9.0 25.9-26.1 28.1-28.3 25.0-25.4 6 Only two of the asbestiform minerals were detected in the products tested Each of these was estimatedby comparison with standards made up by mixing the pure mineral with pure talc invarious 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 The internal standard employed was % by weight of Zn The integrated intensities were summed at the following following diffraction angles ; ve Asbestiform Mineral . Theta Values Summed Me Chrysotile Tremolite : 3 12.0 - 12.4 10.4 - 10.5 24.3-24.8 27.4-27.6 27.4-27.6 30.6-30.91 33.2-33.4 a ae - 29.4-29.7 29.4-29.7 29.4-29.7 tS . . r 4 \ , Page 7 , a & CPC2-00000018 7 Talc was determined by difference 80 The following abbreviations are employed n.d. n.d. n.d. n.d. not detectable = zinc oxide = zinc undecylenate K Kaolin = Caco Caco Caco = Caco = starch calcite phase not identified identified unimportantunimportant because deemed 9 In several instances the same brand of product was pur- chased in different places at different times to on the mixture cConshideerabcle k constancy composition of the mineral Considerable of variations were found See product numbers 14 and 22 22 * wereother precision and 23 , other instances constancywithin the of e.g. the analytical methodwas observed in the case of prod- uct No. 7 Page 8 CPC2-00000019 - Product Number Haim Haim Haim Ihonon Ihonon Ihonon Ihonon Ihonon Ihonon 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 NNGONG NNGONG 29 39 31 32 33 35 36 37 39 40 ~ KEY TOPRODUCT NAMES Product Name Further Identification AMMENS POWDER MEDICATED AMOLIN DEODORANT POWDER AQUAMARINE COOLING SPRAY BATH POWDER BAGATELLE AMBER DUSTING POWDER BOURJOIS BATH POWDER CALDESENE MEDICATED POWDER CASHMERE BOUQUET BODY POWDER CHANEL NO 5 BATH POWDER COUNTESS ROCHEAU CAKE DUSTING . POWDER CREPE DE CHINE DUSTING POWDER MILLOT CREPE DE MILLOT CUTICURA _ CHINE POUDRE MIST , . TALCUM POWDER DESENEX DESITIN BABY POWDER DESITIN BABY POWDER DIAPARENE BABY POWDER . DOROTHY GRAY SECRET OF THE SEA : i DUSTING POWDER EMERAUDE TALCUM POWDER ENGLISH LEATHER FABERGE BIC DUSTING POWDER FRIENDSHIP GARDEN DUSTING POWDER , FRIENDSHIP GARDEN DUSTING POWDER ' PRIENDSHIP GARDEN DUSTING POWDER HEAVEN SENT AEROSOL BATH POWDER MIST HEAVEN SENT BATH POWDER HELEN PRESSL LITTLE LADY : IMPORTA SPAIN MENS TALC POWDER : ISIS FLORAL TALC POU WDM ER , JOHNSON'S BABY POWDER JOHNSON AND JOHNSON MEDICATED i POWDER i KOSCOT BEAUTY DUST OF MINK / LANVIN ARPEGE DUSTING POWDER i LANVIN ARPEGE POWDERED MIST } LANVIN ARPEGE TALC + LEWIS BABY POWDER , LOVES FRESH LEMON GLOSSY POWDER ; MACY'S SCENTED BORATED TALCUM i MACY'S TALCUM APPLE , MARCELLE DUSTING POWDER HYPO- :; ALLERGENIC MARY CHESS PERFUMED DUSTING POWDER Bristol No. IF25 Norwich Revlon 143 Corand DCH Pennwalt 5274 Palmolive Jergens House of Fragrance ' L1132 House of Fragrance Purez 07170 Pharmacraft Pfizer 11392 3/29/72 Pfizer 115A 5/10/72 Breon E1080 Coty 355-4010| Mem 2891 Shulton 3/27/72 Shulton 5/9/72 Shulton 7/13/72 Rubinstein Rubinstein 028Q 3612 1288 Manley & James 2K4 . CPC2-00000020 emnts, Product Name ne MENNEN BABY MAGIC POWDER HENNEN QUINSANA FOOT POWDER MERCK MEXSANA6460 ; NO PRODUCT NO 6460 LOT 6460 2387 MEDICATED POWDER OLD SPICE BODY TALCUM PERSIAN LILAC DELUXE DUSTING POWDER PERSIAN LILAC SPRAY BATH POWDER POND'S PERFUMED TALC BODY B112 H202 8039301 Plough Shulton 7 < April Showers LFN April Showers B200B DEODORANT DREAM FLOWER _ PRINCE MATCHABELLI BELOVED SPRAY 115B : , : POWDER QUEST DEODORANT POWDER REPLIQUE SPRAY BATH POWDER RIVIANA FOODS - ITALIAN STEARIN SEPTEMBER MORN BY POND'S SEVEN WINDS AFTER BATH TALC US P TALC Parfums Raphael 004 TALC- For Rice 19B DuBarry 021085 VASELINE INTENSIVE CARE IVES SAINT LAURENT RIVE ZBT ZBT BABY POWDER ZEASORB SUPER ABSORBENT BABY POWDER GAUCHE SPRAY TALC MEDICATED POWDER I 209 . 1021 Stiefel 1 , L AMBUSH DUSTING POWDER APRIL SHOWERS 9884 AVON UNFORGETTABLE PERFUMED TALC BELOVED PERFUMED DUSTING COTI FACE POWDER RACHEL DESERT FLOWER SPRAY BATH POWDER POWDER PRINCE MATCHABELLI Shulton F 1 BKI EMERAUDE DUSTING POWDER Coty EMERAUDE SPRAY DUSTING POWDER FABERGE FLAMBEAU DEODORANT SPRAY POWDER Coty 1 AEY 37 WBF DUSTING EATH JEAN NATE SPRAY JERIS TALC FLESH JOLIE MADAME DUSTING POWDER POWDER BALMAIN LADY ESTHER FACE POWDERPOWDER RACHELRACHELE MAX FACTORFACTOR FACE POWDER RACHELLE MEDICATED COMFORT POWDER 1 * ; Davis 247 ; 7 OH de LONDON LONDON TO KNOW ME GLOW TOUCH AND TALC Yardley TO LOVE ME - TINKERBELL Tom FACE POWDER CREAMY PEACH 498 Fields Revlon Ltd. TOUJOURS ZOI BATH POWDER Corday HARDLEY APRIL VIOLETS ; 4908 CHANTILLY DUSTING POWDER CASHMERE BOUQUET JEAN NATE TALC MENNEN SHAVE SHOWER TO BABY PURE DREAM > ROND'S TALC ; SHOWER BODY BODY POWDER SHOWERPOWDEPR OWDER DART DRUG PPERFUMED ERFUMED FLOWER + , * ; . Houbigant Houbigant _ E a ' Johnson & 4 TALC . - 381 Johnson 5507BG K. 110 013D 013D . : . ; Page 10 yo CPC2-00000021 Product Number 87 Product Name Further Identification ALMAY ALLERGENIC FACE POWDER CONSTANCE CARROLL BOUQUET TALC DJER TALCUM FLAMINGO DUSTING POWDER TUSSY _ LANDER LILACS AND ROSES TALC . MAVIS TALCON MAVIS BODY POWDER TANGEE ZBT BABY POWDER Kerkoff L1047 Vivaudou Vivaudou Luft Tangee B0048 BLANCHARD'S DUSTING POWDER BORN WILD DUSTING POWDER LANDER GARDENIA AND SWEET PEA TALC LANDER LILACS AND ROSES DEODORANT BODY MISS DIOR DUSTING POWDER TAI WINDS SPRAY TALC Del Labs TALC Avon DCC 1272 2-14-72 2-14-72 TOSCA DUSTING POWDER Pane Pane 11 CPC2-00000022