Document 2j7JGrR9JqQyMdxJwLGVNzD5p

MEMORANDUM DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION T O Heinz J. Eiermann, (HFF-440) DATE: January 7, 1976 Director, Division of Cosmetics Technology THROUGH: Henry M. Davis, (HFF-446) Chief, Product Composition Branch Ronald L. Yates, (HFF-446) Product Composition Branch SUBJECT. Tabulated Results of DCST's Analyses for Asbestos Minerals in Lewin, Field Activity Surveillance (FAS), Investigational and Consumer Cosmetic Talc Products. Attached are a series of tables summarizing data obtained from the DCST analyses of cosmetic talc products for asbestos minerals. Also included, for purposes of comparison, are Dr. S. Z. Lewin's analytical data obtained by x-ray diffractometry. Attachments: Master table. "Summary Table of Results of the Investigations of Commercial Cosmetic Talc Products For Asbestos Minerals by S. Z. Lewin and the Division of CosmeticsTechnology." This table contains analytical data of all the Lewin samples analyzed by DCST. Included is Lewin's data on these samples. b. Table I. "Summary of Results of DCST's Analyses For Asbestos Minerals in Talc Samples Reported by Lewin to contain Tremolite and/or Chrysotile." Information in this table was extracted ntf from the master table and lists only those samples which Lewin ported the presence of asbestos minerals. Table II. "Cosmetic Talcs Analyzed by Lewin and Reported to Contain Chrysotile and/or Tremolite which were not Analyzed by DCST by Either DTA or Optical Microscopy." DCST does not possess the samples listed in this table and, therefore, were unable to analyze them. d. Table III. "Summary of DCST's Analyses of Cosmetic Talc Products by Differential Thermal Analysis (DTA) and Optical Microscopy." This table summarizes, by number of samples, DCST's analyses of talc samples from all sources. PLAINTIFF'S EXHIBIT WCD-94 -2- e. Table IV. "Summary of S. Z. Lewin's Analyses of Commercial Cosmetic Talcs For Tremolite and Chrysotile by X-Ray Diffraction." This table summarizes, by number of samples, S. Z. Lewin's results for all samples analyzed. Ronald L. Yates Product Composition Branch SUMMARY TABLE OF RESULTS OF THE INVESTIGATIONS OF COMMERCIAL COSMETIC TALC PRODUCTS FOR ASBESTOS MINERALS BY S. Z. LEWIN AND TH.5 DIVISION OF COSMETICS TECHNOLOGY(i' SAMPLE # PRODUCT NAME AND MFG. 14 Desitin Baby Powder, Antibacterial; Pfizer 26 Helen Pressl "Little Lady" 29 Johnson's Baby Powder 35 Lewis Baby Powder 37 Macy's Scented Borated Talcum 38 ' Macy's Talcum, Apple 42 Mennen Quinsana Foot Powder 50 Quest Deodorant Powder; 52 Riviana Foods-Italian Stearin Talc; For Rice 53 September M o m By Pond's 54 Seven Winds After Bath Talc; DuBarry 56 Vaseline Intensive Care Baby Powder (same as 130) 57 Yves Saint Laurent Rive Gauche Spray Talc 58 Z B T Baby Powder " 59 Zeasorb Super Absorbent Medicated Powder;'Stiefel 60 Ambush-Dana Dusting Powder 61' April Showers 62 Avon Unforgettable Perfumed Talc 63 Beloved Perfumed Dusting Powder, Prince ^fetchabelli CODE (1139Z) (028Q) (2K4) (H202) (19B) (021085) (1209) (F1021) (9884) S. Z. Levin's Results (X-Ray Diff.) Iiemolite (%) Chrysotile (%) ND<2) ND ND ? ND ND ND ND ND ND ND ND ND ND ND ND ND ND ND ND ND ? ND ND ND ND ND ND ND ND ND ND ND ND ND ND 5% ND DCST's Results Ttemolite (fiber/mg) Chrysotile Optical Microscopy (%) - DTA - ND ND ND ND ND - ND 200 (.02%)(3> ND 600 (.06%) ND ? - ND - ND - ND - ND - ND - ND - ND - ND 700 (.07%) ND ND - ND 36,000 (3.6%) ND SAMPLE # PRODUCT NAME AND MFG. CODE 64 Coty Face Powder -Rachel (Airspun) 68 Faberge Flambeau Deodorant Spray Powder (37WBF) 70 Jeris Talc, Flesh A 6 D 71 Jolie Madaire Dusting Powder, Balmain 72 Lady Esther Face Powder, Rachel 73 A&B Max Factor Face Powder, Rachelle 74 Medicated Contort Powder; Parke-Davis 75 OH! de London Talc; Yardley (498) 77 Touch and Glow Face Powder, Creamy Peach; Revlon 78 Toujours Moi Bath Powder; Corday 79 Yardley April Violets (4908) 80 Chantilly Dusting Powder; Houbigant (IIP) 81 Cashmere Bouquet, Imported White Talcum Powder 82 Jean Nate Talc (on 345) 84 Shower To Shower Body Povder; Johnson & Johnson (5507 BG) 85 Pure Baby Powder, Dart Drug (K11C) 86 Pond's Dream Flower Perfumed Talc 07 Almay Hypo-Allergenic Face Powder (013D) 88 Constance Carroll, Bouquet Talc 09 Djer-Kiss Talcum; Kerkoff 90 Flamingo Dusting Powder, Tussy (L1047) 92 Mavis Talcum; Vivaudou . Levin's Results (X-Ray Diff.) 'Irenolite (%) cHrysotile (%) ND ND ND ND ND ND 3% ND ND ND ND ND ND ND ND ND 3% ND 5% ND ND ND- ' ND:- ? ND ? ND ? ND ? ND ? ND ? ND ? 4% 5% 5% 5% 3% 5% 5% 5% T rero iite l u __ Optical Microscopy (%) - DTA - ND - ND 500 (.05%) ND ND ND ND ND 3,300 1(.33%) ND ND 2,800 i(.28%) ? ? 96,000 (9.6%) ND ND ND ND ND ND - ND - ND ND ND 7,000 (.7%) ND ND ND 2,900 (.29%) ND 4,000 (.4%) ND 7,300 (.73%) ND 'SAMPLE # PRODUCT NAME AND MFG, 93 Mavis Body Powder; Vivaudou 94 Tangee; Luft-Tangee 95 ZBT Baby. Powder 96 Blanchard's Dusting Powder 97 Born Wild Dusting Powder; Del Labs 99 A&B Lander Lilacs and Roses Deodorant Body Talc 100 Miss Dior Dusting Powder 101 Tai Winds Spray Talc; Avon 102 A&B Tosca Dusting Powder 107 Coty Muguet des Bois Dusting Powder 131 Johnson & Johnson Medicated Powder 133 Johnson's Baby Powder 134 Johnson's Baby Powder 135 Johnson & Johnson Medicated Powder 136 Johnson & Johnson Shower to Shower Body Powder 137 Johnson & Johnson Shower to Shower Body Powder 138 Johnson & Johnson Shower to Shower Body Powder 143 Pin-Zow Talque; Perfection Beauty Products, Inc. 144A Overton's "High-Brown" Face Powder 145 Softee Face Powder 148 Lady Wayne Face Powder 149 Solitaire Cake Makeup CODE (B0048) (DCC1272) (2D0) (117110 (108T) (109T) (0452K) (C512Z) (0709X1) (0872K) S. Z. Lewin's Results (X-Ray Diff. Tremolite (%) Chrysotile (%) 5% 4% 4% ? 2% 3% 8% 10% 12% 15% ND ND ND ND 15% ND 10% 7% ND ND trace ND ND ND ND ND ND ND ND ND ND ND ND ND 5% 10% 5% ? ND 2% 2% ND 8% ? DCST's Results Tremolite (fiber/nig) Chrysotile Optical Microscopy (%) - DTfl. 5,100 (.51%) 2,500 (.25%) 300 (.03%) 5,600 (.56%) 13,000 (1.3%) ND trace 60,000 (6%) 8,900 (.89%) ND ND ND ND ND I ND ND ND ND ND ND ND ND ND ND ND ND ND ND ND ND 1,800 (.18%) 400 (.04%) ND trace 3,000 (.3%) ND ND ND ND SAMPLE # PRODUCT NAME AND MFG. 151 Early American Old Spice Talcum Pcwder 152 Corsage Dusting Poder; Lander 153 Airmens Povder, Medicated 154 Bismoline Medicated Powder 155 Rite Aid Pure Baby Powder 156 Warner Pure Baby POwder 157A Mavis Imported Talcum 158- Avon Brocade Perfumed Talc 159 Avon Blue Lotus Perfumed Talc 160 Avon Beauty Dust Refill - Charisma 163 Pinaud Clubman Talc 164 Grand Union Baby Powder 165 Cashmere-Bouquet 167 Tawny Tone Body Talc From Black Heritage; Beauty Mustus, Inc. 168 Colgate Tboth Powder 169 Dr. Lyon's Tooth Powder 170A 173A "C" Bouquet Talc; Winarick, Inc. Corsage Dusting Powder; Lander Co. 175A Lander Baby Powder 176A Lander Lilac & Roses Body Talc CODE (101672) (4212DX) (2662) - s. Lewin's Results (X-Ray Diff.) Trerolite (%) Chrysotile (%) ND ND ND ND ND ' ND 2% ND ND ? 2% ND 6% 8% ND ND ND ? ND trace 10% 10% ND 1% ND ? 2% ND ND ND ND ND ND 8% ND ? ND ? ND ? DCST's Results Tremolite (fiber/mg) Chrysotile Optical Micros^ppy (%)- DTfl ND ND ND 200 (.02%) ND 200 (.02%) 9,000 (.9%) ND ND ND ND ND ND ND ND ND 9,000 (.9%) trace ND ND ND ND ND 6,300 (.63%) - _ ND ND ND ND 7 ND ND SAMPLE # PRODUCT NAME AND MFG. 178A Jean Nate Talc No. 60 194 Tinkerbell Dusting Powder; Ttm Fields,' Ltd. CODE (2264) S. l. Dewin's Results (X-Ray Diff. ITempiite (%) Chrysotile (%) DCST's Results Tremolite (fiber/mg) Chrysotile Optical Microscopy (%)-DTA (1) Results are shown for only those talc products analyzed by both Lewin and DCST. (2) n d - Not Detected (3) DCST trerrolite % is based on following conversion;1000 fibers/mg talc = 0.1% tr: where average tremolite fiber dimensions are 5 x 15 /ilm. If itrassumed that microscopist sees 10% of fibers present, % values would be increased 1 order of magnitude. Sample No. 143 144A 145 148 149 154 156 157A 160 163 164 . , 167 170A - 2* S. Z. Lewln's Results (X-Ray Dif! .) Tremolite <%) Chrysptile (%) 5 10 5? ND 2 2 ND 87 2 ND 2 ND 68 ND trace 10 10 ND 1 2 ND ND 8 DOST S Results Tremolite (flber/mg) Optical Microscopy Chrysotile (%)-DTA 1,800 (.18%) 400 (.04%) ND trace 3,000 (0.3%) 200 (0.02%) 200 (0.02%) 9,000 (0.9%) ND 9,000 (0.9%) trace ND 6,300 (0.63%) -- ND ND ND ND ND ND ND ND -- ND ND TABLE T.I COSMETIC TALCS ANALYZED BY L3JWIN AND REPORTED TO CONTAIN CILRYSOTILE AND OR TREMOLITE WHICH WERE NOT ANALYZED BY DC ST BY EITHER DTA OR OPTICAL MIC]HOSCOPY Sample N o , 66 67 76 91 108 109 111 130 172 183 184 187 188 189 Trento.iite ND 2% 5Z m L ?.win Results (X-Ray Diff.) Chrysotlle 2% ND ND 5% 2 % ND n <y ? 1% trace. 2% 1% 3% ND trace ND ? ND 2 % ND ? 1% 1% ND According to John Stuart's notes, the above samples are not present in the lot of Levin's samples Inventory of Levin's talcs verified that DCST does no t possess the above samples. Analytical Method Source Total Analyzed Chrysotile Detected Tremolite Detected TABLE III SUMMARY OF DCST'S ANALYSES OF COSMETI C TALC PRODUCTS BY DIFFERENTIAL THERMAL ANALYSIS (DTA) AND ORTICAI, MICROSCOPY (OM) S . Z . Lewin Differential Thermal Anal ysis FAS Investiga zional and Consu uer 78 76 2 5? (2) 0 0 NA NA NA Optical Microscopy S . Z . Lewin FAS Investigaclonal and Consumer Ln "P L 47 00 30 0 11 0 0 (1) Includes 25 of 37 samples In which S. Z. Lewin reported presence of tremolite by x-ray diffraction* DOST detected treimolite in 22 of the 25 samples. DCST detected tremolite in 8 samples where S. Z. Lewin reported none detected. (2) Results on all 5 samples were ambiguous ue to interferences and/or low levels of chrysotile. TABLE IV SUMMARY OF S. Z. LEWINTS ANALYSES OF COMME RjCIAL COSMETIC TALCS FOR TREMOLITE AND CHRYSOTILE BY X-RAY DIFFRACTION Wo. of Samples Analyzed 195 Samples Only Chrysotlle Detected Sam])les Only Tremolite Detected 24 Samples Tremolite and Chrysotlle Detected 13