Document mqEydzYeD2RDMe7BN3j2MO4yB

FILE NAME Johnson & Johnson JAJ DATE 1974 DOC JAJ230 DOCUMENT DESCRIPTION SVC Pamphlet - English Translation Barry Castleman Comments - In English it has a section on talc in cosmetics starting at p 25. On 27-28 it is noted that health departments accept hard silicates tremolites chrysotiles at traces level On 28 it is noted that many talcs have hard silicates tremolites chrysotiles etc. and that Pinerolo SVC talc has hard silicate contents extremely low only traces Societ^ Talco e Grafite k Val Chisone The harmful harmfhularmful elements according to pharmacopoeias and cosmetics Asie USEPHARMACEUTIC fa OF TALCS OF PINEROLO IN PHARMACEUTIC PHARMACEUTIC PHARMACEUTICC OSMETICCOSMETICSECTORSECTOR JNJMX68_000009502 ~ 3 id e 3Q aft aft aft aft th th jae " Publishebdy SOCIETA TALCO E GRAFITE VAL CHISONE Piazza Garibaldi 25 - PINEROLO Telef 0121 71.214 - Telex N. 21.639 Telegrammi Valchisone a Forbidden reproduction a avin 5 JNJMX68_000009503 PRACTICAL GUIDE wey TO THE RECOGNITION nek OF IMPURITIES erty IN TALC summary PRESENCE AND DIFFERENTIATION OF ACICULAR FIBROUS AND FASCICULAR CRYSTALLINE FORMS IN TALCS Tremolite - Actinolite - Chlorites STRUCTURE OF ACICULAR : ma MATERIALS UNDER THE MICROSCOPE yg Chrysotile - Amianthus fibres - Amphi- je bole fibres - Actinote - Amphibole GA amianthus - Fibres and small scales from tremolite pag 3 a @. IMPURITIES xa PRESENT IN TALC r ' cua The harmful elements Suistewad according to pharmacopoeia and cosmetics Introductions - General Remarks SURVEY OF THE ELEMENTS CONSIDERED HARMFUL BY THE PHARMACOPOEIAS AND ON WHICH INFORMATION IS GIVEN ALSO IN COSMETOLOGICAL STANDARDS 43, Tonal Iron - Lead - Arsenic - Copper - Nickel and Cobalt - Titanium Chrome Cadmium - pag 19 Gitte y USE OF TALCS OF PINEROLO IN PHARMACEUTIC - COSMETIC SECTOR pag 25 a REMARKS ON THE ' GRINDING OF THE TALC Extraction - Treatment of the unrefined material - Grinding the tale pag 31 a eat ~~~ JNJMX68_000009504 ~ PRATICAL GUIDE TO THE RECOGNITION OF IMPURITIES IN TALC we ve ia of JNJMX68_000009505 PRESENCE AND DIFFERENTIATION OF ACICULAR FIBROUS ney AND FASCICULAR CRYSTALLINE FORMS IN TALCS eS a a ~~ + ee . eee . eer @ om a ev. a ' !! eee) 1' ee ee ee ae ee ay fe a oy ae et eee SO ee Recent regulations state that for cosmetical or pharmaceutical use a talc must be free from acicular and fibrous particles of amphibolic or serpentine type . e free from serpentine amianthus or asbestos or at least if present it must be in a minimum quantity a It is first of all necessary to give an exact interpretation of the terms mentioned amianthus asbestos amphibole amianthus serpentine amian- thus and by inference actinolite tremolite and other similar crystallisa- tions that have very varied mineralogical terminology but can be reduced , to these fundamental types It must be explained first that the terms amianthus asbestos are synonyms and so indicate the same physical state amianthus from the Greek atuavros means incorruptible and is the same as asbestos ac" which means inextinguishable . e both terms indicate that these fibres are indestructible by fire Though they have a vegetable or animal appea- _ rance our ancestors discovered that they could not be destroyed by fire Let us consider Serpentine first According to Artini the chemical composition is as follows H Mg Si0,0 . e 2H.0 3Mg0 - 2 Si0 and in percentage H = 0 13 Si0 = 43.35 Mg0 = 43.65 It is never crystalli- sed in distinct forms but almost always in aggregates that sometimes have a lamellar structure and sometimes fibrous very fine aggregates are especially common with interwoven lamellae or fibrils that are abso- lutely compact to the naked eye Hardness 3-4 Specific weight 2.62.6--2.7 22.6.-27.7 Not very brittle It is always a mineral of secondary origin formed by . alteration of other silicates principally olivine Pyroxenes too especially rhombics give rise to serpentine _ & 3 3 w e sof 4 < JNJMX68_000009506 A variety which is remarkable in appearance is the fibrous variety which fills the lithoclases in rocks formed of compact serpentine If the fissure is narrow and the fibres normal to the walls are fairly rigid and and silky . coarse then we have CHRYSOTILE the colour is greenish the brilliance is splendid photograph ) If the fibres are white longer often oblique to the walls of the or aggrega shades up Somet forms ami lithoclases flexible soft we have the filamentous variety called amian- CHLORI Ai thus or asbestos photographs 2 and 3 Et We will now go on to the amphiboles As far as chemical composition is concerned they are similar to pyroxenes that include a large number of The ch to micas b ak silicates of magnesium iron calcium and sometimes even aluminium and sodium mainly of a metasilicate type rarely pure and more often formed alkalis the have a dis of fairly complex isomorphous mixtures Its prevailing habit is short thick of alumini ld prismatic and the physical properties vaty regularly with its composition so that the specific weight which is = 3.1 where it is richest in magnesium reaches 3.5 where it is more ferriferous always ver etymology Accor Amphiboles monoclinc can be divided into non aluminiferous and of two sili a aluminiferous the latter being the more numerous The former are the a. result of an isomorphic mixture of two silicates Mg Ca Si0 and Fe Amesi Recent contain Man- Ca Si0 . e Mg Fe Ca Si0 Some also Titanium and but form a a ganese within the Ee The chief varietieosf amphiboles include tremolite actinolite nephrite The lai oan horneblende etc. group of pl Bad Tremolite and actinolite interest this survey in particular because of comes from whead their fibrous and filamentous structure composition valences of TREMOLITE * formed of 1 Oe forming a I 5) ee This is the name given to the monoclinic amphibole resulting from Looking Ca Mg Si0 when it is pure or nearly pure In percentage it is 4 Si0 ===== - is consider ae 57.57 Ca0 = 13.43 3 Mg0 = 29.0 It is formed in very long bacil- folia that d , ay lary crystals mostly aggregated or fasciculated that are white in colour In talc . photograph 4 is as follow ACTINOLITE This is called also actinote and is the amphibole in which a notable quantity of Ca Fe Si0 is found associated with the silicate of tremolite This mineral is also in long prisms photograph 5 that are intercluded In chlo ~ fact it belo chlorite et of talc is i JNJMX68_000009507 iety the and cilky .an- Hon of ach and DSL iabnsof med Thick it tion he one- _ and att the Ainsabldwtbthesd Fe Man- ei Age rite ai Bea te of from J Dacilcolour hes, Stable Geanco olite tial luded itil aii or aggregated and sometimes rayed The colour is green greeny blue or shades up to bottle green Sometimes actinolite is filamentous with fairly flexible fibres and forms amianthus from amphibole CHLORITES The chlorites present a certain similarity morphological in particular to micas but they differe from them essentially because they are without alkalis the lamellae are less thin and less foliaceous and because they err have a distinctly basic character Chemically chlorites are basic silicates of aluminium magnesium and iron without alkalis The hardness is always very low unlike the micas and the colour is always green Greek etymology According to Tschermak true chlorites or orthochlorites are mixtures of two silicates in different proportions serpentine and amesite Amesite H Mg Al Si0 is much more basic than serpentino Recent research and opinions maintain that chlorites are not mixtures but form a clearly defined mineralogical group of their own though still within the large complex of schistose rocks The large number of crystalline forms of chlorites are included in the group of phyllosilicates foliaceous silicates in which the crystal lattice comes from the superimposing of folias or strata of a definite chemical composition that are fixed in their structure by precise chemical valences of the constituent elements In this specific case the strata are formed of tetrahedrons of Si0 placed in a mesh of hexagonal shape and forming a lattice that stretches without limit in both surface directions Looking at the crystalline structure in this way we can see that there is considerable difference between chlorite and talc because the strata or folia that determine the crystallisation are different In talc there is a sequence of identical strata the unitary composition is as follows OH Mg Si 0 In chlorites and chiefly in clinochlore the chlorite nearest to talc in fact it belongs to the series of chlorites Pennine Sheridanite Prochlorite etc. the crystal lattice is not so uniform the specific folium of talc is intercalated and divided by another formed by brucite If JNJMX68_000009508 . we consider also the possible and frequent replacement of magnesium and silicium with iron and aluminium the crystal structure of clinochlore or chlorite we have the following appearance in nature 7 Si Mg Al OH | Si 0,0 stratum of talc whith posible possible repreplace-lace- ment by aluminium Mg OH brucite stratum As can clearly be seen from the above description even the physical characteristics of the two minerals talc and chlorite are considerably different In the first place the hardness of chlorite is more than double that of talc and reaches from 22.5 22.5 22.5 in general compared with talc which being first on the scale has a hardness of 1 As far as specific weight is concerned there is no difference worthy of mention chlorite also like talc has values that vary from 2.6 to 2.8 though in talc it is nearer 2.8 and chlorite tends towards 2.6 As regards coiour even though the term correctly indicates the chro- maticity of this mineral it is not rare to find in nature chlorites and clinochlorites that have a white - nacreous appearance owing to the scarsity of iron as a replacement element of Magnesium and Silicium and which could be classified as pure talcs after a superficial examination The differentiation between talc and chlorite is very easy when they are examined under a microscope First of all the unitary stratum struc ture of talc gives rise to very thin and soft lamellae which cannot be obtained with a heterogeneous foliated structure like that of chlorite In the second place there is the colour of the lamella which under the microscope is always transparent colourless for talc and tending towards a fairly definite green for chlorite If the minerals are observed under polarised light the interference colours are also very different in the two mineral varieties they are almost existent for talc and bright for chlorite The final but not least important consideration is the different way in which talc and chorite behave with acids and heat Talc is insoluble in acids even when concentrated whereas chlorite when subjected to a lengthy treatment even only on steam bath will show its high solubility Of course everything we have set out here about the differentiation between talc and chlorite is very important when we are considering the use of these products for pharmaceutical and cosmetical purposes JNJMX68_000009509 Le Dalia From the pharmaceutical point of view the greater solubility of chlo- eD Sh ys rite is a highly negative factor as is also proved by the requirements of ot i. pharmacological standards concerning the solubility of talc for such . en wag purpIonsetshe cosmetological field the hardness of chlorite which is double at least that of talc makes it an element that is clearly in contrast with eo the need for very soft materials such as talc for dermatological treatment TOMS. especially for infants or for very delicate skins or people affected by skin diseases In fact in this case it is the solubility itself together with the ALAR hardness that can cause the greatest harm since the soluble parts the replacement elements of the recurring crystal molecule are the very ones that are most dangerous and harmful On this question see the booklet TY Impurities present in talc - toxic elements ta bate JNJMX68_000009510 | - STRUCTURE OF ACICULAR - FIBROUS MATERIALS UNDER THE MICROSCOPE CHRYSOTILE This crystallisation is examined first because on account of its form chemical It is the most dangerous Recent research seems to show a and physical differen- anes tiation between chrysotile and what we call asbestos that is the substance feiat that is most known and used for fireresistant textiles and materials Since here we are dealing with a mainly microscopic examination . we can say first that Chrysotile shows itself in the form of rectilineal thin fairly brittle needles Furthermore it is this needle itself that presents the greatest dangers for the skin and for the internal mucous tissue when It is absorbed or inhaled or makes contact with internal cavities of the body varies from These needles are always coloured and their chromaticity pink bright red often with shades of yellow from which comes criso xpicos gold the root of the name AMIANTHUS FIBRES They can be of different types and colours The prevalent colour is a slightly pinky white and there are also shades that go from pink to bright red and from pale green to dark green and bottle green There is the short and thick form of the fibres that has rounded ends interlacing lengthened and clearly visible characteristic lattice within the fibre inside that formsa 11 JNJMX68_000009511 fe: JNJMX68_000009512 ws gous wou JNJMX68_000009513 it 0 a cr | AS A 4 tle tia Ge eI Ba we Poh tot There are also very thin fibres that unwind from a fairly compact skein they can be linear in very short fragmentosr curved in the longer * ones Fibres which seem single in body have however streaks all along the filament and end in a small brush which is sometimes clean cut and some- times in irregular bands as far as the length of the fibrils is concerned as , they broaden out at the ends There are compact darker fibres that are contorted with knuckle bends and at these points they have a node formed by a crystal of silicate serpentine ... ; The inclusion of small fragments of silicate in the fibres is a characte- ristic of amianthus from serpentine Finally we sometimes find in certain serpentinous mineralsa short thick almost linear form of amianthus fibre that is usually coloured reddish and is very hard photograph 6 AMPHIBOLE FIBRES - ACTINOTE - AMPHIBOLE AMIANTHUS If these are coarsely ground or if they are residual fragments they are always linear flow fibrils or fascia The single fibres are rectilinear needles that are white or rarely coloured light green to dark green Often the group opens at the ends to free the fibrils in a fan shaped form as is characteristic of the amphibole present in Chinese talcs photograph 7 - 8 It is possible to have fairly long single almost linear fibres FIBRES and small scales FROM TREMOLITE Tremolite is often found as a pure clearly separate and distinct cry- stallisation in the mineral which it occours or rather in the host mineral When it is found in talc it takes on a particular characterisation in that it tends to transform itself into talc both as far as structure and chemical composition are concerned As regards the structure the presence at the same time of both fairly short and fine needles and lamellae can be clearly seen This corresponds to an incomplete metamorphosis of the silicate or rather the change from tremolite to talc is not complete Owing to Interruption of the evolutionary process or the ceasing of suitable conditions tremolite remains in an intermediate form as far as crystallisation 12 is conc of soft Lo stalline and ke stal fo has be charac .C the h solid menta thus ! a Pa JNJMX68_000009514 waft 0 ye |: ee is concerned but it is already complete as far as physical characteristics of softness and composition are concerned photograph 9 . Long crystal forms are rarely found especially since the macro stalline form is segmentary and no longer fibrous in the interclusion itself and keeps a certain degree of hardness owing to constriction during crystal formation in the host mineral however once the apparent structure has broken the constituent disaggregates lose the roughness that is characteristic of tremolite and adopt a certain degree of softness away Calcium Ca0 the soluble part of tremolite was washed at the high temperatures and pressures which were present during the solid reactions before the solidification of metamorphous rocks and sedi- | mentation the earth's crust and has been in part replaced by water , thus giving rise to metasilicate of magnesium f . oe Si 5 Bean wait, Fesetgy: ay vost JNJMX68_000009515 oo : | bo 4 - { 1 { q .: ' IMPURITIES PRESENT IN TALC | . i a 5 ~ The harmful elements according to pharmacopoeia - and cosmetics . me ia Pe Bos A brief enquiry talcum powder into the presence of harmful elements in from the pharmaceutical and cosmetolo- gical point of view Contents of lead titanium iron arsenic copper and chrome are axemined in detail on the basis of tolerances established by the standards that regulate this : field ~ . nt , af af _ 20 . . . JNJMX68_000009516 P 4 } ] 7 ; F aes ee a 3 INTRODUCTION The mineralogical origin of talc is still discussed today and in spite of different theories that convince to a certain extent there is no cer- tainty at all The reason for this is that talc is very widespread and is found in rocks that are fairly dissimilar from each other and amongst metamorphical material of different origins physical This fact explains however the considerable differencesin structure and the large range of impurities that are foundin talcs coming from different countries or regions It is worth pointing out that pure talc i e metasilicate of magne- sium is formed only of silica magnesia and water However pure crystallisations are fairly rare in nature and talc is also subject this rule As has been said talc can contain impurities that depend on the environment of its formation and can be determined by the original rocks by promiscuous sedimentation by scouring or by the contribu- - tion of clastical elements present during its formation These elements which are oxydes silicates carbonates and sulphurs vary greatly both as regards presence and quantity quantity quantity amongst talcs of dif- ferent origins In fact to a certain extent they are a peculiar characte- ristic which sometimes permits the origin of the talc to be recognized with some degree of certainty Of course it is these impurities themselves that decide the value of a talc not because of their presence however but because of their absence GENERAL REMARKS Talc is present in many pharmaceutical preparations as a constituent and is the basis of many cosmetics so that the authorities responsible for public health have rightly been ' concerned to establish standards that set the limits of tolerance as regards potential or actual impurities that are harmful to man and present in talc Since there is as yet no international unification of the standards adopted in different pharmacopoeias or cosmetologies we will quote each those that in our opinion are more suitable or more precise in their specifications Another consideration which we feel is necessary concerns the opinions about how toxic different elements are since here too there are differences from one country to another or indeed from one researcher to another. As an example we can consider boric acid in which according to the latest views a degree of toxicity has been ascertained but which all pharmacopeias prescribe as a disinfectant in spite of the fact that , it is a bacteriostatics and in no way disinfectant - 20 SUR BY THE IS G IRON In talc and even in far as mine tite and pyr they are re Increases c different cc fluence con In its fi used to gril The VII in water 1 minutes Fil acid the s potassium f The Enc according to 0.8 mg per 0 for the s a cosmetolo tions for pu ding to phar cleatsna -'e JNJMX68_000009517 SURVEY OF THE ELEMENTS CONSIDERED HARMFUL BY THE PHARMACOPOEIAS AND ON WHICH INFORMATION IS GIVEN ALSO IN COSMETOLOGICAL STANDARDS IRON } t ' i > es i : In talcum powder iron can be found in different mineralogical forms and even in the form of free iron The most common compounds of iron as far as minerals are concerned are magnetite haematite siderite pyrrho- fos tite and pyrite These compounds generally have a low solubility but when they are reduced to the fineness to which talc is ground their solubility Increases considerably It is also necessary to take into consideration the different conditions of use to which they are subject and which can in- ;" .* 7 tm i- j fluence considerably their solubility e g pH concentration heat etc. In its free state iron derives Ste mainly the that used to grind the talc from wear of machines are The VII edition of the Italian Pharmacopoeia gives Ferric salts soluble In water 10 g of talc are kept in b m with 100 ml of water for 15 minutes Filter A part of the filtered liquid is acidified with hydrochloric acid the solution must not colour blue with the additon of solution of potassium ferrocyanide The U.S.P. XVIII is practically the same The English one is more precise in that it prescribes a quantity test according to which the maximum tolerable limit of iron soluble in water is 0.8 mg per cent For iron soluble in acid the limit rises to 0.20 % as Fe 0 for the standard taken from the American and English specifications of a cosmetological nature and 140 p p m according to the Swiss regula- tions for purified pharmaceutical talc purified is specified since accor- mi ding to pharmaceutical regulations for purified talc is intended talc treated ; 21 Poe Sa JNJMX68_000009518 : OP . zs: oe NE Sve Wome 7 we Py Wicd Rr TONY ds ROT oe ete NOT TU i hae TOT i) ge TR OE aE a: EE aT etttd iin cL FN with diluted hydrochloric acid and washed thoroughly with water in this practically way the remaining iron is reduced no longer dealing with natural talc to a few p p m and we are The other pharmacopoeias Dutch Belgian French Swiss etc. generally refer to the above mentioned standards or are less severe than those given above as for example cosmetics In fact the T. G. A. prescribes a maxi- mlu evel ofm 0.75 of Fe20 soluble in acid Even if the methods given in the different specifications do not correspond exactly the quantities given and defined as limits are fairly consistent and a large number of production control tests on the best brands of Talc of the Val Chisone fully satisfy all the requirements both pharma- ceutical and cosmetological as far as iron is concerned -_ The level of iron soluble in water of SVC talcs for pharmaceutical and cosmetological purposes in accordance with the various methods is much lower than the standards Iron soluble in acids does not reach the level of 0.1 compared with the 0.75 of the T. G. A. LEAD This element is not found in talc in its free state Its most common and known mineral is galena lead sulphur PbS with 86.6 of Pb The hardness of these crystals is fairly low in fact it barely reaches 2.5 consequently the ease with which they can be finely reduced and the Increase of their solubility is considerable even more since this mineral is often found in very finely grained minute aggregates where the aggregate is fairly easy to destroy The pharmacopoeias and cosmetological standards are rightly fairly severe as far as this element is concerned as it is well known for its toxicity Generally speaking we find limits that reach 20 p p m of Pb whereas others usually add together lead and heavy metals and give a limit of 40 pp m Looking at the pharmacopoeias we have 70 p p m for purified pharma- ceutical talc but this quantity comprises lead and copper together others give 20 p p m as a limit and in general refer to the U. S. P. XVIII The methods of analysing lead can vary from the classical ones of scholastic analysis to sophisticated modern methods relying on date equipment In each case however there is no discrepancy in the results The pharmaceutical and cosmetic qualities of SVC talcs are so pure that the level of lead in them is very far from any of the limits given above - 22 5 fro AF tal pyi ; thi hy me any pha tol fro -- is dis oxi de cal lim su me NI toc tio . t The im tal JNJMX68_000009519 In fact taking into consideration the normal fluctuations for a product from a mine the quantities vary from 0 to 1 2 p p m ARSENIC This metalloid is not found in a free state as an element in ground talc It derives from arsenious and arsenic compounds and from arsenious pyrite which are fairly common in nature The peculiar characteristics of . this element are its volatility its ease of reduction and the formation of hydrogenate compounds in special reductive and hydrogenate environments Because of these characteristics and because of its high toxicity in any form the limit allowed is fairly low and varies from 2 to p p m in pharmaceutical and cosmetological standards all over the world The level of arsenic As in SVC talcs for pharmaceutical and cosme- tological use varies from 0.3 to 0.7 p p m maximum in other words far oon from the limits generally set COPPER . This element is found also in a free state in nature however in talc it is usually found in the sulphide double sulphide and rarely oxide state This element is not often mentioned in the standards we have been discussing but it should not be overlooked because its toxic action as an oxide is considerable and as its influence as a catalyst in coagulation and _ densifying processes To go outside the specific field of cosmetology we can give as an example the rubber and plastic sector in which very precise limits are set for the content of copper in talc . As far as copper is concerned once again the best SVC talcs have such low contents from 2.5 to 4 p p m that they can meet any requirements for use and processing in any industry - NICKEL AND COBALT These two elements are treated together because they usually occur ae - together in nature too They are of more interest for industry as was men- eee tioned for copper than for pharmaceutical and cosmetological purposes They are dealt with here therefore because we are considering all the ye, Impurities present in talc and to give further proof of the purity of SVC talcs in which the content of these metals does not exceed 9 p p m - 23 ll Re ieee tele oe react a ee - ~~ bay , at JNJMX68_000009520 TITANIUM Titanium is very common in silicates It is usually in the form of rutile or titanium dioxide Its hardness of 6.5 places it amongst the crystalline forms that can be harmful if present in talc used for care and treatment of the skin e in cosmetics Its relatively high density also creates problems of uniformity in suspension and mixtures This fact is also met in other si- milar crystalline forms and causes marks spots etc. in the finished product especially if the talc has not been ground with sufficient fineness These dangers or disadvantages that come from titanium minerals are not present in SVC talcs either pharmaceutical or cosmetic since their Tio content reaches a maximum of 0,08 CADMIUM According to very recent research carried out also by the Italian Minister of Health and his Institutes cadmium has been recognised as accumulated being highly toxic especially bacause it is urganism the kidneys in particular by the human - The limits of tolerance which have already been sest et in other countries are in process of being established in Italy too The level is very few p m In consideration of the purity of SVC talcs we can already affirm that they will be satisfactorily within the limits that shortly be set for this elements CHROME We have intentionally left this element to the end because at present considerable research is being done especially because it is accumulated and there is no way in which they it owing to its high toxic level and by animal and vegetable organisms can eliminate it The Public Health Authorities who are very concerned about this matter have introduced very severe standards to ensure that pollution from this element hexavalent chrome by industry is kept to a minimum We ourselves have car- ried out very careful research on the level of chrome in SVC talcs especial- ly those for pharmaceutical and cosmetic purposes so as to ensure that these products fully meet all health requirements The level of chrome in SVC talcs is about 0.01 a quantity that is so low that it ensures maxi- - mum safety in use 24 ts, Viens JNJMX68_000009521JNJMX68_000009521 d . =2 b Sou fe P ad .al- . nat axi- USE OF TALCS OF PINEROLO | / IN PHARMACEUTIC : . SECTOR . a: ; | JNJMX68_000009522 JNJMX68_000009522 It is known since many years that some talcs with more peculiar che- physical characteristics may be defined the bestin the pharmaceutical- cosmetic sector _ This is determined by incontestable characteristics of mineralogical structure and by an extremely low impurity content Talc impurities may be classified as follows Very hard silicates as chrysotiles and tremolites of amphibolitic deri- vation namely with strict asbestos content 2 Chlorites that can also reach 60 Moh's hardness of 3 at least 3 Noble chlorites they reach up to 60 Moh's hardness 2 4 Calcite dolomite ankerite quartz actinolite ferromagnesium silicates oxides of different nature iron plex sulphides manganese or titanium simple or com- It is considered today in modern cosmetology although if not officially - controlled by Hygiene Offices or by Health Departments the acceptability tremolites of tolerance for hard silicates as traces level or chrysotiles see n 1 at Soft silicataerse considered to be dangerous when their percentage becomes much far higher in comparison with the aggregate mass content ) , : 27 . ~ JNJMX68_000009523 As per analysis a many talcs have a hard silicate content t lites chrysotiles etc. reaching also the 10 tremo- also b other talcs of various origins have a soft silicates content that can reach the 60 chlorites etc. With that we think to have been sufficiently clear about the characte- ristics of talcs available for the cosmetic market The talc of Pinerolo for cosmetic use that's mined from the deposits of the Chisone and Germanasca Valleys in the Western Alps has to be considered as a product of very high quality because ) the hard silicate contents are extremely low only traces as it is demonstrable by the testings of qualified Technological Institutes ratio it is and jute thro ment whit volt purp 2 the content of soft silicateiss also very low our talc is nearly free 3 the impurities stated in point n 4 can be considered practically negligible 4 its structure that is extremely lamellar not fibrous and not needle- unctuosity shaped and unciform guarantees the highest degree of soft- ness and smoothness at touch Te In fact it can be clearly proved by practical tests of microscopic magni- a: fication e g electron microscope that a shaped structure by the absorption on the part of pores can badly corrode the cellules of a a tissue because if we want to make an exemple the point of a knife is F<: always more hurtful than the flat surface of the same amit. The acknowledgment of these peculiar characteristics common only to athe very few talcs present in bulk on the crust of the earth brought to it an niche undiscussed international favour This is at the basis of the very strong Country Cit current of exportation established since many years towards every of the world All our talc is deeply mined from deposits ranging between 200 and 600 mt under the surface It is included between the characteristic rocks of this part of the Alps gneiss schits and dolomitic limeston it is extraneous and very far from every horizon of serpentine and asbestos rocks that could invalidate its purity It is exploited in accordance with an sini - 28 - e we, am OTST . Te eR ede areas JNJMX68_000009524 j 30 = i - to 4 j de- de- de- . yo: _ rational mining techniques that defend from every possible pollution and it is processed in special mills located west of the town of Pinerolo Talc is previously subjected to sorting crushing and drying processes and then it is ground in special closed circuit mills and packed in paper or jute or polythene bags of 25-50 or 100 Kgs For cosmetic uses a fineness is generally required allowing 99-99,5 through 200 mesh sieve 6200 meshes p sq cm For special requirements it is also micronized to the finenesses of 30-20-10 microns As to . whiteness it oscillates according to the types between 90 and 95 Photo- volt points absolute value The actual production of Soc Talco e Grafite Val Chisone for cosmetic purposes amounts to 45.000 tons a year 80 of that is shipped abroad gli- gli- gli- alesoft- agni- by of a fe is . we ly to an ; | Strong iy untry I and rocks i it is Bestos . os , - . . . Pa 2 ry a? a : : s : ae deat ins 0 st bi YE eee ad ae AY a Pai aceite, sey ee | . a eT ite JNJMX68_000009525 REMARKS ON THE GRINDING OF THE TALC any Grinding reveals the hidden structure up its virtues if the of a material it shows material is of good quality or heightens its defects if there are On the other hand, if the grinding is not done well and to a sufficient extent, it can have a terial and lower the quality of bnoetghative effect on the ma- racteristics appearance and cha- Aaheafiwo4 ee Ye ae to at nae thes JNJMX68_000009526 THE GRINDING OF TALC AND ITS DEGREE OF FINENESS IN RELATION TO ITS USES FOR PHARMACEUTICAL AND COSMETOLOGICAL PURPOSES | epe SOs Talc is the main constituent of rocks that are generally known by the mak names of Saponites Steatites and schists A large number of industrial Sh. products from the earth classified as talc contain a large variety of other minerals such as chlorite serpentine tremolite dolomite calcite quartz etc. The ideal composition of talc is a silicate of magnesium hydrate Mg Si 00 OH from this formula the percentage composition can be calculated Sio 63.5 in weight Mg0 31.7 in weight HO 4.8 in weight os; Slight changes of composition are found in the natural product crag Talc like mica has a lamellar structure in which a layer of magnesium ions is sandwiched between two layers of tetrahedral silicon These layers or lamellae are electrically neutral so no additional cation such as po- ein tassium can be inserted between them as is the case with mica It is Important to recognize the complete symmetry of the superficial characte- ristics of talc which makes the two faces of each individual layer perfectly identical Owing to the lamellar structure and the neutralitoyf the surfaces there is a definite trend towards the delamination of the talc wich is ~33 - JNJMX68_000009527 linked also to the smoothness between the layers that reveals the well known lubricating properties of talc itself The layers are held together by ; the Van der Waals force London type . The accumulation of individual lamellae one on the other does not follow a logical order and the difference revealed by rays was not sufficient to make the problem clearer reason must be sought in the limited cohesion of the lamellae to each other which enables them to take up different orientation with respect to the others without difficulty Amongst other things this property explains the well known softness of . talc Because of the lamellar structure of talc special technological procedures are required in order to reduce it to a fine powder The elastic and very smooth lamella makes the grinding process particularly difficult especially when we consider that it is necessary for the product to conserve all its physical characteristics of softness and greasiness since it is these characteristics that distinguish it and make It a principle material for cosmetology and when we consider the absolute ' necessity of avoiding all pollution or contamination so as not to reduce the high degree of purity wheint is used for pharmaceutical products chara there press by th elimi the s main of ul lecti first down mine TREA whe of fi and EXTRACTION The talc of the Western Alps which is reserved mainly for these - uses is all extracted underground from layers of triassic age made up of gneiss and schists with masses of dolomite of varying size interposed The genesis itself of this type of talc entirely excludes the that presence of serpentinous rocks or derivatives of other talcs of different origins form the parent rock Present extraction of the talc takes place at a depth between 200 and 500 m below surface This depth is essential to ensure the biological purity of the mineral especially when all technical measures are taken to avoid or limit its contamination It is in fact obvious that the conditions are very different when the mineral is extracted from open quarries or mines where the protection from external agents is of limited efficiency Day by day mining experts with many years of tried experience teas. supervise the work of extraction in order to exploit only the purest mi- laboratory neral They are aided in their work by the timely material extracted analysis of the first drie talc cont ther reqi talc fror JNJMX68_000009528 well er by not not the Quity Quity - of pro- cess for and Lake biute suce e ee cnr mine cae Mese Made size tA the rock and ical _ken ions s or ncy ncc . mi- the Ssh ectiins - The mining sistems for extraction are conditioned by the physical characteristicosf SVC talc and are indeed specific for the purpose since there is extensive use of reinforcements to counterbalance the very strong pressures that occur in the stopes Another requirement is represented by the waste filling operations after the mining which are necessary to eliminate as far as possible dangerous empty spaces that may remain in the stoping areas The operation of mining and reinforcement must still be entrusted mainly to the manual work of highly skilled workers thought with the help of date machinery A peculiarity of this mining activity is the selective mining that is carried out on the layer of talc which is in fact a first quality selection of the material to be extracted This operation slows down output but is nevertheless one of the basic factors that ensure the mineralogical purity of the product TREATMENT OF THE UNREFINED MATERIAL There are two very modern works situated on an important highway where the unrefined mineral is ground to reduce it to the different degrees of fineness that are required today the modern technologies the use and processing of powdered talc The talc that comes from the mine packed in special crates undergoes first the processes of crushing and sorting It is then treated in rotary driers to remove moisture These driers of the tubular kind in which the talc does not come into contact with the combustion products are a valid contribution to the biological purification of the mineral As proof of this there are the results of recent analyses which are given separately For particular products where the highest degree of whiteness is required an electronically controlled optical sorter is used in which the talc previously prepared in pieces of the same size is checked by rays from photoelectric cells and selected according to requirements Further proof that the raw material is treated under the best possible _.. conditions is that all the mineral is transported on specially designed mechanical shovels or conveyors to avoid the introduction of foreign substances as happens for example in a manual treatment In fact the con- taminating effect of the soles of the workers shoes is sufficient to pollute skin a material that is destined to end up on a baby's delicate tablets of a medicine or in the Even if SVC talc is extracted from mines and not from the open as has been mentioned it can still contain microbes anaerobic or aerobic - 35 - oma gnRNeAS mE Dea trey, NS ny a Ts U2 be Lon ee ee OMT lame JNJMX68_000009529 | t { sl 4 1a 4 alt, SRM ati hie =a, alin alicecle on bacteria that have been brought by the machinery the miners shoes or any other equipment that comes into contact with the unrefined matter To eliminate this contamination from bacteria much as possible the unrefined mineral goes into and sterilizing ovens that were mentioned before spores and germs as the continuous drying | The oven several meters long and contains a large number of pipes inside that work as heating elements It rotates on its longitudinal axis at a slight inclination so that the material moves forward at a calculated speed in order to give maximum sterilization The temperature reaches treatment achieves over 240 and this together with the time of intended purpose the In order to show how efficient the use of this series of ovens is tests have been carried out to analyse the quantity of bacteria contained in different samples of powdered talc produced from material treated in different ways The samples were numbered ar follows no 1 fine unrefined talc exposed to all weathers and subjected to con- workers shoes ground tamination by the treading of In the drying ovens but not treated no 2 unrefined talc in pieces as above not treated in the drying ovens fine no 3 unrefined talc exposed to all weathers and the treading of - workers shoes ground after treatment in the drying ovens Quantity of bacteria in 0.1 g 2 3 Cultures in aerobiosis no of colonies 5700 900 100 Cultures in anaerobiosis no of colonies 800 50 50 Cultures for research of sporogenous species no of colonies 100 10 20 In addition no sign of fecal pollution was found in any of the samples These analyses were made by the Institute of Hygiene of the University of Turin on January 24th 1974 In another analytical report by the same Institute but which was made for control purposes at a different time there is the following information Quantity of bacteria in aerobiosis and anaerobiosis - 36 - The samples Res Res = cons Bac stantly anthraci The a few sa ' that the Whe in a me GRINDIN - Grir research In a chief ch to choos squashin paration to expel pyrite centages Ther Pinerolo product through : fineness ---- Impact k Thes and enci situated tional nu roughly t JNJMX68_000009530 different The semination even of a gram of the material from the samples led to the development of only a few colonies Research for fecal indication = constantly negative anaerobic Research for pathogenic sporogenous aerobic and = constantly negative 1 species Bacteriological tests carried out on samples of SVC talc have con- specific Bac stantly demonstrated the absence of anthracis Pl tetani germs CI Weichii The fact that in all the samples were present as an exception only ie a few saprophytic bacterial units per gramme of seminated matter means Lens that the product can be considered a practically sterile cla. _ When is comes out of the sterilisation ovens the is te mechanical mineral carried in shovel to the grinding mills re i GRINDING THE TALC SERBBataes Grinding is the main operation in the treatment of talc and much research and technological experience ha gone into its realisation In order to preserve the lamellar structure of our talc which is its ee chief characteristic from the large range of machinery it was necessary Se to choose pendular mills in which trituration takes place by means of eee squashing the particles They work a completely closed cycle and se- paration of the product is done pneumatically Some are fitted with devices ae to expel particles of a greater hardness generally formed of impurities oe pyrite quartz dolomite chlorite but in any case in very small per- centages There are ten pendular type mills installed just for the talc of the ee Pinerolo region of between 100 and 150 HP each The fineness of the product to which they are adjusted is between 99 and 99.8 passage optimal ee through a USBS sieve of 200 mesh opening 74 microns This is the prweny e fineness for the cosmetics industry grinding mills the eeee To achieve greater fineness second are in use of ay ee Impact kind that are called vertical mills Cones product These mills in which the ratio between quantity of obtained Ce and energy used is very low give different degrees of fineness all bank situated below the USBS 325 mesh sieve and indicated with the conven- ae tional number of the Fisher diameter 1.50 -1.20 -1.20 - 1.05 which corresponds roughly to a fineness of 30 microns 20 microns and 10 microns - 37 . yo JNJMX68_00"000J9NMX68_50095331 1JNJMX68_000009531 Further grinding is done by means of fluid energy micronizers using our case the expansion of air compressed to 7 atm At present they give a product that is about 6 microns and indicated with the Fischer diameter of 0.80 ; The ground product is conveyed pneumatically in stabilized bins of different capacities and is then usually packed in 50 Kg bags for talcs of a normal fineness and 20 and 25 Kg bags for micronized talcs An Installation for dispatching the loose product in tank trucks and tank wagons has recently come into use To return to comments on the processing we can add that when the product is homogeneous as far as structure and composition are con_ cerned the work of grinding is established by the physical and mechanical parameters of the product itself and the working of the machine is de- termined by the basic structure of the mineral that is to be treated If however the mineral is not homogeneous other factors or para- - meters enter into the milling process that are determined by the characte- ristics of the various components If we examine these characteristics we find in the first place the . hardness of the components then the structure which includes the clea- vage according to specific predetermined planes of the mineral or a conoid breakage and in certain cases as is clearly seen in Chinese talcous minerals the crushing is conoid and granular up to a certain point after wich the grain which is usually shapeless realises small squat lamellae which are thick on the surface and in this way reveals its true original structure In this latter case fine grinding has shown up the real basic structure et of the mineral _ With a mineral that is rich in chlorite as is the case with some Eu- ce ropean products a fairly similar phenomenon occurs with fine particles i UE that are not very different from each other As has been shown in another part of this report there is a clear ee difference both in hardness and crystallographic structure between talc 2 and chlorite The hardness of chlorite is more than twice that of talc and Its basic lattice is formed of two layers whereas that of talc has only one , During the process of disaggregation which occurs with the grinding operation it is obvious that talc reduces to extraordinarily thin and soft lamellae which could not be obtained from a crystalline structure with two layers - 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