Document 1QV5k2xqa0RkO8yGV1Kmnz74o

FILE NAME: Johnson & Johnson (JAJ) DATE: 1972 Oct 27 DOC#: JAJ059 DOCUMENT DESCRIPTION: Report - Examination of J&J Baby Powder with Cover Letter & Note that Study is Being Redone HKMUMO~MXWrNr JPJQfcflaom at}ajqns->umnooq pO M yuj rinrfia.>*fci>1. n u A J *. ...M iA .m . ..a  'matter c. m e n J ... eon. 27 October 1973 t> V JA ~ i *y Or. A. J. Gaudi 1 r jotasoii end Johnson Besearch Center SOI George Street Ke Brunswick, New Jener 08801 Deer Dr. Gamite: Bere is our report as tke baby powder simples. I hive to heve Sie Shower to Shower report out to you soon, but something always seen to break loose heu I sit down, to write it. P ro te c te d D ceu m m i" S u b je c t to P ro te c tiv e o n h r J&J-0059870 JNJM XM L000012024 O r. A. j . Goodie Johnson and Johnson . R esearch C enter 501 George S treet New' B riinsw lck, New J e rs e y OS901 < EXAMINATION . or JOHNSON AND JOHNSON'S BABY POWDER Data: 27 O ctober 1972 MA Numbar: 2546 Copy 2 1 of -4 . waiter c. mecrone associates, inc. 2820 SOUTHMICHIGANA VSNUE CHICAGOJLUNOIS SOS16 P rateeM Deeummrt-SutyKtto Proteetiv Order E X H IB IT i 52- JNJMXeajMOOOUHS T EXAMINATION OF JOHNSON ANI) JOHNSON'S BABY POWDER Suipmanr Two sam ples of Johnson and Johnson's Baby Powder, batch number 108T an d l0 9 T , which correspond to .the sam ples examined by Professor- Seymour Z. Lewin of New York U niversity on behalf of the FDA have been examined by x-ray diffraction, light microscopy, transm ission electron microscopy and elec tro n diffraction to determ ine whether they contain any asbestiform m in erals. Both sam ples contained aninsignificantam ount oftrem oltte -- a few isolated crystals. Neither sample contained chrysotile. Introduction On'behalf.of the FDA, P ro fe sso r Seymour Z . Lewin of New York University is examining a number of com m ercial talcum powders for the presence of asbestiform m inerals. Two of the sam ples which he has examined a re sam ples of Johnson and Johnson's Baby Powder, batch number 108T and batch number 109T Johnson and Johnson therefore requested W alter D. McCrone A ssociates to ex- . amine sam ples from the sam e batches to determ ine whether they contained any asbestiform minerals. ! M aterials and Method of Conducting. T ests . Two sam ples w ere submitted, identified as Johnson and Johnson's Baby Pow der, batch num bers 108T and 109T. F o r x -ray diffraction examination, the samples w ere examined on a Fhillips-N orelco v erticle diffractom eter using CuKa radiation and a scanning speed of 1" p e r m inute. The d ispersion staining technique was used for th e light m icroscopical examination and the electron m icroscopy-electron diffraction ex amination w as c a rrie d out using procedures previously, d escribed (MA re p o rt 2330-1; dated 10 August.1971). P rotected D ocum ent-Subject to Protective O rder waiter a mccrone associates, inc. JNJMX68 R esu lts X -ray Diffraction The diffractogram s were carefully examined in the vicinity of the . major peaks of chrysotile. and trem olite. Neither m ineral was present. The presence of peaks in the vicinity of 12.0-12-5 29 , {he region in which one of die principal lines of chrysotile may he found, was correlated with peaks in the vi cinity of 6* 20 and a re thus attributable to chlorites.. No significant peaks w ere observed in the 24* region which would be req u ired w ere ch rysotile p resen t. Light Microscopy Using the dispersion staining technique and a liquid of refractive index 1.550, the sam ples were examined for. qhrysotile p articles and fib ers, but none could be found. Using a sim ilar technique with a liquid of refractive index 1.805, the sam ples were' sim ilarly examined for the presence of trem olite and a few individual cry stals were found, some rod shaped. Electron Microscopy and Electron Diffraction Several- electron m icroscope grids from both sam ples w ere ex amined in th eir entirety and although som e fib ers w ere observed these w ere shown by electron diffraction to be sh ard s of talc o r rolled ta lc . No chrysotile fib e rs w are found. Conclusion A detailed examination of two sam ples of Johnson and Johnson's Baby Pow der, batch num bers 108T and 109T has shown this m aterial to be sub stantially fre e of asbestiform m inerals. A few trem olite ro d s w ere observed in both sam ples; No chrysotile has been detected. Respectfully submitted, Ian M. Stewart Manager, Electron Optics Group waiter a mecrone associates, inc. Protected D ocum ent-S ubiect to Protective O rder JNJMX68_000006937