Document mbbY2J7zenV9pD9yYJy82D1g0

SUMM/VRY AND COMMENTS ON ANALYSES FOR AS3EST0S IN COSMETIC TAL.C,PRODUCTS ^liis summary contains the analytical results for asbestos in cosmetic talc preparations, comments on these analyses, and other pertinent information on the work carried out by the following investigators: 1. Seymour 2. Lewin, Ph.D., Professor of Chemistry, New York University. Dr. Lev/in was commissioned by FDA in 1971 to analyse commercial cosmetic talc products. I3c purchased * and analyzed 195 samples by x-ray powder diffraction. Dr. Levin was chosen because he is an internationally recognized expert on mineralogical chemistry. 2. Arnold E. Schulze, Microanalytical Branch, Division of Microbiology (BF-216), FDA. Mr, Schulze investigated 32 of the 195 samples by moans of polarizing microscopy. -3 . Minerals, Pigments and Metals Division, Pfizer, Inc, Easton, Pa. This investigator employed the techniques of x-ray powder diffraction and reported on 7 of the 195 samples. This work was complimentary. 4. Columbia Scientific Industries, Austin, Texas. This firm chi:eked samples for chrysotile by means of differential thermal analysis. This work was complimentary. There is poor correlation between Dr. Lewin's results and the findings of the other investigators. Dr. Lewin found definite indications of chrysotile in 17 of the samples (many of these also had tremolite) and definite indications of tremolite but not chrysotile in 23 samples. The chrysotile content could not be confirmee with certainty by the ' other investigators, and tremolite was detected by the others only in a few instances. The reason for these discrepancies may be found in Dr. Lewin's own. notes of July 10, 1973, in which he stated: "The. chrysotile that I found in commercial talcs is generally different in significant respects from the chrysotile that occurs as massive, fibrous growth in veins in serpentine rocks. That is, the former hgs diffraction peaks that may differ from the latter by as much as 0.2 A- (at 7.3 A) ; it is more reactive toward dilute acids: it shows a diffrent appearance under the microscope; and its D T A endothermsand exotherm are shifted relative to those of the latter (and apparently diminished)." He further states that "the analy tical method (x-ray diffraction" gives a reproducah: ty of +_ 2% to 3t average deviation in replicate determinations on th,, =amc sample, but 'different samples from the same bulk container are found to vary as much as 2001." In the light of these discrepancies and because the inhalation of certain asbestiform minerals is a potential health hazard, the FDA has engaged in an intensive research project to tievolop one or several methods of suffi cient sc-nhitivity and reliability which will j-erAit the dct.ornination ci asbestos in talc-containing prpduct:; with the- necessary dr grau of &r-::ie--ey and at concentrations at which this contaminant .present.1: the health hazard. H einz J. Eiorraann: 10-1-73 P L A IN T IF F S E X H IB IT CAM-187 ITA-LG 00161 ITA-LG 00162 S a fiM S Y TABLE OF RESU LTS OF FOUR INVESTIGATORS ON A N A LY SIS OF COMMERCIAL COSMETIC TALC PRODUCTS FOR ASBESTOS MINERALS AMPLE PRODUCT NAME & MFG, CODE 63 Beloved Perfused Dtg. Pvdr, P rin ca M atch ab elli, (Chesebrough-Ponds) G6 Sn erau d i Dtg. Fw dr.,(Caty) * 6? 3=raude Spray D ig. P v d r., (CotyJ 1AEY 71 Tollc Madame D tg. Pwdr, B o ln a in , (Revlon) 76 ? a :>xow :-:e i e to lo v e He. T in Jte rb e ll, (Tan P ie ld e , L td . - 77 E'oech a Glow P ace P w dr., Creamy Peach, (avion} 78 Toujoura Hoi Bath Pw dr:, (Corday) 52 C onstance C a r r o l l , Bougueg, - S3 Djer-Kiss Calctn, (Xertoff) 90 Fli.cd.ngo Dtg. Pudr., (Tussy) Si Leaser Lilacs S Hoses Talc, 92 Mavis Talcum, (Vivaudou) L1047 "A J * S3 Mivi3 Body Pwdr., (VivsiudouJ Ta.'.ceu f {Luft-T&nepifc) S3 32T Baby PjH e , -11 j1 _ -, - i90048 CHRY30TILE , 5-2 - Lewin X-Ray D iffr- (A )* A.E. Schulze P fiz e r Coluatb. S c i . Opt. M icros. X-Ray D iffr . D iffl flierio.Ana. fB)* (O * (D l* TREMOLITE (A)* U K, <C). .3L n.d. 2 4 ,' n.d. n .d . w - - _ n .d. n .d. 5% 54 52 54 5% 44 3% ^ AaU. n.d. - n.d. - _ ' n.d. - n.d. - _ - -- "t - - +. - 54 n.d. 24 34 5: 34 St 5ft n.a5v> 54 4a 2*. 7k.a. n .d . __ ---- _ s.a. Cl.h. 1-1. l.a. 1.*. 1 - l.a. l.a. - . --- _* -_ aw . 1.91 * 4 - '1 " ; % I1 ITA-LG 00163 SUGARY TABLE OF RESULTS OF FOUR INVESTIGATORS ON ANALYSIS OF COMMERCIAL COSMETIC TALC PRODUCTS FCR iSHiSTOS MINERALS PRODUCT NAME & MFC i sa Blanchard*e Dusting Pwdr., (Del Labs.) 97 Zorn Wild Dtg. Pwdr., (Del Labs.) 101 i'ai Winds Spray Talc, (Avon) 1C2 Tosea Dtg. Pwdr108 Revlon Intimate Perfused Bath Pwdr. 1C Z Eate Bath Pwdr., [Lanvin-Ch&rles of -ho 3it2> 111 Old Spied Body Talc, (shulton) 133 Vaseliie Intensive Care,(Ckesebrough-Ponds) 131 Johns-an. & Johnson Kedic&t^&d Pwdr, .'Johnson & Jchnson) 1-33 Pir-lov Talcua,(Perfection seauty Products) 1-33 Overton's "High-Brown" Face Pwdr. 335 Soiree Free Pwdr. 4 Lady ifayse Face Pwdr. .14jf Solitaire Cake Makeup 153 Elamaiine Medicated Pwdr. COD - 241 2137 MFC - CHRYSQTILE S.Z. Lewin A.E. Schulze Pfizer Columb. Sci. X-Ray Diffr. Opt. Micros. X-Ray Diffr. Diff. Therm Ana. (A)* (B)* (C)* 10) * TRE,"OLITE <)" Is)-- (Cl" (=; - 10 + n.d. + 8% ' , 0.75 - 154 n.d. ,n.d. + 17 l.*.; s.i-. - n.d. 7 n.d. n.d. - - - 15 1TM - - - 10* I.el. - - - 2% - - + Tl.de tr - - . --- 14' 'tr - ---- n.d. 104 + 2 n.d. n.d. ~ *> " - - tr - - * - 5% - - - - 51 - -- - n.d. > -- - 24 -- - &% - - .- - 21 S.. C.S'j *- A- i