Document oDXwDpn9xMJObB1bvqb8erw1X

FILE NAME: Johnson & Johnson (JAJ) DATE: 1996 Jan DOC#: JAJ028 DOCUMENT DESCRIPTION: Memo RE Cosmetic Talc CPTA 1995 Reissue with Cover Letter CONSUMER PRODUCTS WORLDWIDE SKIILMAN, NJ 08558-9418 January 29, lan Phillipson Head of Scientific Services The Cosmetic Toiletry & Perfumery Association Limited Josaron House 5/7 John Princes Street London, W 1M 9HD Dear lan, RE: Talc W orking Party Please find attached a note to myself from Bill Ashton who is a long serving talc expert in J&J. I showed Bill a draft of the CTPA guide for his comment. As you see, he has some concerns on the matter of tremolite. The issue is whether there should be any concern over non-fibrous tremolite. I have a lot of respect for Bill's views on details such as this and would propose that you might sound out Fred Pooley on this matter. If the final CTPA monograph is not yet issued to print, could you consider helping resolve this issue as soon as possible. You-will see from the second paragraph of Bill Ahston's letter that there are long-standing and wider issues also. I will phone you to discuss when you have had time to consider. Kind regards. Y oi-- !------- * ' JHjk A ttach m en t T a lc W P John Hopkins Protected D ocum ent-Subject to Protective Order JNJNL81 000013746 r* -f.: ' t a COHFIDIM TIAI January 22, 1996 TO: J. HOPKINS FROM: W. H. ASHTON SUBJECT: COSMETIC TALC CTPA 1995 REISSUE Attached is page eleven of the current issue o? ft, CTPA. QjtfKlfl. wherein Fre^Pooley makes the suggestion that any batch of cosmetic talc which reads positive fo&he presence of amphiboles, should be"rejected even if subsequent examination establishes whether or not the mineral is fibrous or non-fibrous. We need clarification on this since it is in conflict with ail work here in the US based primarily on the mineral tremolite which is present in trace amounts in many high grade talcs. The mineral tremolite is chemically a calcium magnesium silicate and occura in two crystallographic habits: fibrous, which is called tremolite asbestos, and prismatic or non-fibrous, which is not asbestiform. Hera in the US a controversy has been underway for the past 25 years. All agencies and health oriented groups have accepted the view that only the rare fibrous tremolite might be hazardous as opposed to the harmless prismatic form. This has been fought at many meetings of science groups and in the courts, mainly spearheaded by the R. T. Vanderbilt Co. who sells large tonnage of tremolitic talc to the ceramic industries here and abroad. I have spoken to John Kelse, Corporate Industrial Hygienist for Vanderbilt who is concerned about the CTPA position. It turns out that they have Fred Pooiey on retainer for some of their European industrial talc problems and I would not be surprised that Kelse might call Pooiey. The details in the main body of the CTPA spec call for X-ray methodology, which can be capable of seeing as tittle as 0.1 % of the tremolite or other amphibole in talc substrate. Perhaps you know someone in the UK who could call Pooiey and find out what he really means by the new look of equating fibrous to non-fibrous forms of the associate mineral in talcs of our grade. W . H. Ashton Protected Docum ent-Subject to Protective Order JNJNLS1 000014013 S J ----- Fibrous Mineral.* Amphlbol* The inhalation hazards o f fibrous minerals have long been recognised (IS , 16, 17). The CTPA view is dun fibrous minerals should not be detectable in a cosmetic talc by `state of the art' methods. As the description o f die mineralogies! processes involved in the formation o f talc may have shown, amphiboles are possible contaminants: these include tremolite, anthopfayllite, actinolite, etc. Tremolite, the most common amphibole contaminant, occurs only rarely as the fibrous form, and the varieties o f massive trem olite which under the microscope appear to contain fibres, commonly comprise mainly thick fibres or cleavage fragments which do not present the same hazard as asbestos. However, in order to eliminate any hazard to the consum er which might arise from the seed to interpret fibre shape and dimensions,^and to facilitate routine screening, the CTPA view is that if ah'amphibole is detected t$*X-rey diffraction, that batch o f talc is .unacceptable for cosmetic ,use, whether or not subsequent exam ination by optical or electron microscopy shows that the contaminant is not fibrous. In this respect the CTPA Specification is even more stringent than others which refer only to fibrous amphiboles. Chrysotile is classed with the asbestos minerals but is not one o f the amphiboles, which have a chain silicate structure; it is a sheet silicate, as are talc and chlorite. Chrysotile has been reported to occur in certain talc deposits, notably in New York State (18), but it has not beat found in talc from sources used in the UK. L3___ S illca /flu artt W orkers exposed to quartz dust over a period o f y ean may develop silicosis, but the risk out. be minimised if the drily exposure to respirable particles o f quartz is not allowed to exceed a certain value. That value is determined by the average concentration o f respirable quartz dust and is currently set at 0.4mgm`' (19). A CTPA funded study showed that a consumer may be exposed to a concentration of respirable talc up to about 2 mg/cu.m during use o f talc products (2), but this is only for a few minutes per day. It can be shown that the 'safety factor' for the consumer is at least $00:1 compared with the permitted occupational exposure limits. Thus the consumer is not exposed to any ride o f silicosis from quartz in cosmetic trie. S.4 C hlorite To a mineralogist, `chlorite' is not one mineral but a family, varying considerably in com position but all having a layered structure which gives some chlorites a `slip' sim ilar to talc. Chlorites are widely distributed and re often die consequence o f the hydrothefmal alteration o f parent rocks related to those which give rise to tries by similar processes, so they would be expected to be common contaminants o f ta k . Cosmetic Talc-A CTPA Guide Copyright @ 995 - The CTPA Ltd. -11- Pnriccted Docum ent-Subject a Protective Order JNJNLS1_000014014