Document pmVbJ02nJ67OOkqRDe1Eox6bX

* November 22, 1974 TO: FROM: RE: R. E. Norwood H. D. Stanley Results of the Last Two CTFA Round Robins for Asbestos in Talc Analysis Attached please find the results of the last two Round Robins of the CTFA committee on talc analysis. As you can see, we at Pfizer did well on all samples except one; Sample B in the third RR. A meeting to discuss these results is planned for December 9 at Bristol Meyers. I plan to attend. Harold D. Stanley HDS/imb attachments 0017844 C TPP. CONFIDENTIAL PFI KA 00000756 11713679 CONFIDENTIAL PFI KA 00000757 < .-------- - M r. G. Sandland C hairm an, CTFA C om m ittee on A sbeetoe in T alc SU B JEC T: RESULTS O F ROUND ROBIN ANALYSIS (#2) USING PRO PO SED CTFA "COOKBOOK" PROCEDURES FOR THE DETECTION O F ASBESTOS IN T A L C . _________________ The CTFA T ask F o rc e on M ethodology for the detection of asb esto s in talc for co sm etic use has com pleted its evaluation of two "cookbook" procedures for the detection of ch ry so tile and asbestiform am phibole in c o sm e tic g ra d e ta lc . T h ese two m ethods fo r a s b e s to s , would a s s u re th at a talc Is 9 9 .0 to 99.5% fre e of a sb e stifo rm m in e ra ls. The ta sk fo rce co n sisted of the following m em b ers: M r. W alter Luckew lcz (Avon) M r. Ian Stew art (M cCrone A ssociates) D r. Joseph Sim ko (C olgate-P alm olive) M r. H arold Stanley (P fizer) D r. C. F . Thom pson (V anderbilt C o .) M r. J a c k S chelz (Johnson It Johnson) M r. D avid H a m e r (Jo h n so n It Jo h n so n ) D r. D. H a rris (Cyprus Industrial M ineral Company) I To te s t the two pro p o sed "cookbook" p ro c e d u re s, the following products I w ere purchased locally by m e: C a sh m e re B ouquet (lot #4813), A m m ens P ow der (lo t I4C13), JOHNSON'S B aby P ow der (lo t #282Y) and R ap tu re (Avon). C yprus and P fizer subm itted talc sam ples for the round robin analysis since these com panies do not have a co m m ercial product on the m arket D r. John S tu a rt of the DFA a lso subm itted two unknown sa m p le s, labeled FDA-1 and FD A -2 . To fu rth e r te st the m ethods, a spiked sam ple con ta in in g 2% c h r y s o tile a s w e ll a s a s a m p le c o n ta in in g 0.75% tr e m o lite w e r e p i e p a r c d . A ll th e s e s a m p le s w e r e c o d e d by m e and a s tro n g m u s k p e r fum e oil was added to each sam ple to hide any identifiable perfum e odor. E ach ta sk fo rc e m em b er receiv ed for an aly sis in his lab o rato ry s e v e ra l gram s of each of these coded, perfum ed talc sam ples. The "cookbook" p ro c e d u re fo r d etection of c h ry so tile in talc re q u ire d the use of a D ifferen tial T h e rm a l A nalyzer (DTA), which at the tim e of the ro u n d ro b in a n a ly s is o n ly A von and Jo h n so n It Jo h n so n had in th e ir la b o r a to rie s. H ow ever, C olgate-P alm olive, P fizer and M cCrone A ssociates a re c o n sid erin g the p u rc h a se of a DTA unit a t p re s e n t. Of the eleven coded talc sam p les, Avon and Johnson k Johnson detected chry so tile in only two * T ra d e m a rk of Jo h n so n It Jo h nson t 0017845- . ,t ---- . CONFIDENTIAL PFI KA 00000758 11713680 CONFIDENTIAL PFI KA 00000759 k' 37- - 2- s a m p le s ; th a t is , in th e sp ik e d 2% c h r y s o tile - ta lc s ta n d a rd a n d in FDA-2. A fter the analysis was com pleted. D r. S tuart of the FDA r e v e a le d th a t F D A -2 c o n ta in e d 1% c b r y s o tile s p ik e d (by h im s e lf) in . talc. The "Cookbook" p ro ced u re fo r the detection of fibrous am phibole in talc was c a rrie d out on the coded sam p les in th e la b o ra to rie s of M e Crone A sso c ia te s, P fiz e r, C olgate and Jo h n so n It Joh n so n . P ositive re su lts for am phibole by x -ra y d iffractio n a t a level of 0.5% o r h igher w ere found in the follow ing sam p les: Investigator and R esults Coded Sam ple M cCrone Colgate Johnson & Johnson P fizer 0.75% T rem olite C y p ru s (SUP 200) 2% C h r y s o tile in talc (SUP 200) C y p ru s N Y T-3FL A m phibole Found m n none d e te c te d A m phibole Found u not run A m phibole Found A m phibole Found N A m phibole Found m not run ft A m phibole Found it I P o ssib le positive re s u lts fo r am phibole a t low lev els (below 0.5% ) w ere i found by different in v estig ato rs in other ta lc : in the round ro b in , but th e re I w as no unanim ous a g reem en t and in m ost in stan ces the in v estig ato r w rote j "am p h ib o le?". The follow -up m ethod of m icro sco p y to see if the am phibole I m in e ra l detected w as a sb e stifo rm w as done by P fiz e r and by Johnson k | Johnson on the sam p les in the above ta b le . Both P fiz e r and Johnson k j Johnson found, by m icro sco p y , m assiv e o r n o n -asb estifo rm am phibole in i th e 0.75% tre m o lite and C yprus N Y T -3 F L . T h e se sam p les w ould p a ss the te s t. Both la b o ra to rie s, how ever, failed C yprus SU P 200 sin ce it con tained asbestiform am phibole. The in frared m ethod fo r the detection of tre m o lite in talc was applied to these round robin sam ples by Avon. P ositive re su lts w ere obtained for th e 0.75% T r e m o lite , C y p ru s S U P 200 an d 2% c h r y s o tile (S U P 200 t a lc ) . T his m ethod looks p ro m isin g , but fu rth e r w ork m u st be done to see if it I 0017846 ' iBav- - .rkJS i Ii CONFIDENTIAL PFI KA 00000760 11713681 CONFIDENTIAL PFI KA 00000761 t_ - 3- c ta also d etect am phibole m in erals o th er than tre m o lite . S w as su g g e s te d th a t th e LR m eth o d m a y be a b le to d e te c t w h e th e r o r n o t the trem o lite p resen t is asb estifo rm . SUBJECT: ROUND ROBIN (#3) ANALYSIS FOR CHRYSOTILE IN TALC USING TH E PROPOSED O PT IC A L M ICROSCOPE PR O C E D U R E .____________________________________________ Since the DTA p ro ced u re w ill not d istin g u ish betw een c h ry so tile (fibrous serpentine) and antigorite (non-fibrous serpentine) a backup optical m icroscope procedure for chrysotile was developed in the c a se of a p ositive reading by DTA. T h ree coded ta lc sa m p le s, of w hich two contained c h ry so tile w ere subm itted to th e ta s k fo rc e . T he resu lts from these scientists able to perform the analysis w ere as follow s: Investigator and R esults Coded Sam ple Lucy & W alter M cCrone M cCrone A ssociates H. Stanley D. Hamer P fiz e r J o h n s o n fc Jo h n so n A - Talc Sam ple from P fizer containing chrysotile and A ntigorite none detected pass c h ry so tile found - fa il C h ry so tile found fa il B - 1% C h r y s o tile in Talc prepared by a sim ulated in d u strial m illing p ro cess. ch ry so tile found fail none found pass C h ry so tile found fa il C - 1.2% fib ro u s ta lc none found in platy talc. pass none found pass none found pass The task force can recom m end the use of the x -ra y dlffraction/optical m ic ro sc o p e p ro c e d u re for am phibole and the DTA p ro c e d u re fo r serp e n tin e (c h ry so tile), how ever, round robin #3 does not support the validity of the backup o p tical m icro sco p e p ro ced u re to the DTA p ro c e d u re . 0017847 < / - -'wf F . R obert R olle, Ph. D. C hairm an, T ask F orce on M ethodology fo r the D etection of A sbestos in T alc ! CONFIDENTIAL PFI KA 00000762