Purpose: To investigate one historic brand of cosmetic talcum powder associated with mesothelioma in women.

Purpose: To investigate one historic brand of cosmetic talcum powder associated with mesothelioma in women.

Purpose: To investigate one historic brand of cosmetic talcum powder associated with mesothelioma In women.

FILE NAME: Colgate (COL) DATE: 2014 DOC#: COL040 DOCUMENT DESCRIPTION: Journal Article - Asbestos in Commercial Cosmetic Talcum Powder as a Cause of Mesothelioma in Women Asbestos in commercial cosmetic talcum powder as a cause of mesothelioma in women Ronald E.

I am a repeatedly author in the reviewed literature including a 22 book chapter on Naturally Occurring Asbestos NOA for ASTM International ASTM as well as articles on the science of asbestos talc including cosmetics geology and mineralogy 23 and have given numerous asbestos presentations to various organizations including the Environmental Information Association EIA formerly the National Asbestos Council the 24 American Industrial Hygienist Association AIHA and ASTM 25 8.

I am a repeatedly-published author in the peer-reviewed literature, including a 22 book chapter on Naturally Occurring Asbestos (NOA) for ASTM International (ASTM), as well as articles on the science of asbestos, talc (including cosmetics), geology, and mineralogy, 23 and have given numerous asbestos-related presentations to various organizations, including the Environmental Information Association (EIA) (formerly the National Asbestos Council), the 24 American Industrial Hygienist Association (AIHA), and ASTM. 25 8.

Exposure Data Introduction Talc refers to both mineral talc and industrial mineral products that are marketed under the name tale and contain proportions of mineral talc that range from about 35 to almost 100 The mineralogy of airborne particles in talc mines is restricted by that of the deposit and associated rocks Therefore mines and mills provide an opportunity to characterize exposure to one specific source of talc mineralogically In contrast the mineralogy of talc in an industrial setting where talc products are used may be difficult to characterize because many different sources of talc are available for almost every application Industrial talcs are quite variable in their talc content and in the identity and proportion of other minerals that they contain In addition talc is part of a complex mixture of materials in user industries Talc particles are normally plate When viewed under the microscope in bulk samples or on air filters they may appear to be fibres and have been identified as such Talc may also form as true mineral fibres that are asbestiform asbestiform describes the pattern of growth of a mineral that is referred to as a habit Asbestiform talc fibres are very long and thin and occur in parallel bundles that are easily separated from each other by hand pressure Asbestos is a commercial term that describes six minerals that occur in the asbestiform habit actinolite anthophyllite chrysotile grunerite riebeckite and tremolite IARC 1977 Similarly to talc these six minerals occur more commonly in a nonasbestiform habit and may also be elongated without being asbestiform Actinolite anthophyllite and tremolite may occur in some talc deposits when asbestiform they constitute asbestos and when not asbestiform they are referred to as mineral fragments or cleavage fragments -277- 278 IARC MONOGRAPHS VOLUME 93 1.1 Chemical and physical data 1.1.1 Nomenclature CAS Registry No 14807-96-6 Chem Abstr Name Talc Synonyms : Soapstone steatite talcum Trade names Trade names of industrial cosmetic and pharmaceutical talc include Agalite Asbestine Australian microcrystalline Beaver White 200 CP 10-40 CP 38-33 Crystalite CR 6002 Desertalc 57 Emtal 500 Emtal 549 Emtal 596 Emtal 599 Ex Fibrene C 400 Finntalc French Chalk FW HSDB 830 IT Extra LMR 100 Microneeca K1 Micro White 5000A Microtalco IT Extra Mistron Montana talc MP 25-38 MP 40-27 MP 45-26 MST MT 12-50 Mussolinite CO6018 Nytal 200 Nytal 400 Pk Pk Plustalc Polytal 4641 Polytal 4725 Snowgoose Steawhite Supreme Supreme dense Talcan PK Talcron CP 44-31 and Westmin Rocks or mineral composites that contain talc mineral include agalite potstone soapstone and talcite Soapstone generally contains at least 25 of minerals other than talc while talcite is sometimes used to describe rock that contains at least % talc Harben & Kuzvart 1996 Steatite originally referred to a rock that is relatively pure talc today it denotes a ceramic body with a high talc content that is used as an electrical insulator The tale that is used in such applications is known as steatitic talc French chalk is soft massive talc Piniazkiewicz et al 1994 Talc has also been referred to as snowgoose agalite and kerolite Industrial talc generally refers to products that contain abundant minerals other than talc cosmetic talc now normally contains 98 talc Zazenski et al 1995 but the content may have been lower in the past Rohl et al 1976 Pharmaceutical talc contains 99 talc Talcum powder is cosmetic talc Zazenski et al 1995 Pyrophyllite is similar to tale in atomic structure but contains aluminium instead of magnesium Al2Si4010 Bish & Guthrie 1993 the two minerals do not occur together in nature although they have similar industrial applications 1.1.2 Structure of the typical mineral Chemicalformula Mg3Si4010 Molecular weight 379.26 The original ray spectra of talc Gruner 1934 Hendricks 1938 indicated that mineral talc had a monoclinic structure Later investigations Ross et al 1968 Rayner & Brown 1973 demonstrated that talc is triclinic Table 1.1 The small deviations from 90 in angle a and angle y result in the triclinic symmetry Indexing the ray diffraction ' These synonyms and trade names cover talc materials that contain talc and tale that is contaminated with other minerals as admixtures TALC 279 pattern as a monoclinic structure assumes that angles a and y are each 90 and doubles the magnitude of one of the lattice parameters parameter c in Table 1.1 Table 1.1 Lattice parameters and crystallographic axes of tale Lattice parameters nm a b Crystallographic axes - B Y System References 0.5255 0.5293 0.9137 0.9179 0.9448 0.9496 46 57 55 91 00 03 Triclinic Triclinic Ross et al 1968 Ray & Brn owne 19r 73 The structure of talc is characterized by a hexagonal sheet arrangement of siliconoxygen tetrahedral groups linked in a common plane Each oxygen tetrahedron shares three planar oxygen atoms with its neighbouring tetrahedra the fourth oxygen the apex of the tetrahedron is not shared Two such sheets are orientated so that unshared apical oxygen atoms face each other The sheets are bonded by magnesium atoms that are coordinated octahedrally by two oxygen atoms from each tetrahedral sheet and two hydroxyl groups This structural arrangement results in a double structure in which the valence demands of the constituent atoms are completely satisfied without interlayer cations these double units are held together only by weak van der Waal's bonds The double units are easily separated by slight forces that result in a perfect cleavage direction in the basal plane Rohl et al 1976 Pooley & Rowlands 1975 The structure of talc is depicted in Figure 1.1 see cover photo of this Volume 1.1.3 Chemical and physical properties of mineral talc Hardness 1 on Mohs scale Density 2.58-2.83 Cleavage 001 perfect Colour Pale to dark green or greenish grey to black also white silvery grey brownish Luster Translucent pearly greasy or dull Indices of refraction Talc is biaxial with 1.539-1.550 1.589-1.594 and 1.589-1.600 The indices of refraction increase with iron content Because "and y are approximately equal talc appears to be uniaxial Deer et al 1962 Description Commonly thin tabular crystals up to 1 ...min width talc is usually massive grained and compact it also occurs as foliated or fibrous masses or in globular stellate groups Talc particles are normally thin and plate but the size of the individual plates varies among different bodies of ore When viewed under the microscope on end talc platelets may appear as fibres Cralley et al 1968 These are not true fibres and should not be confused with asbestiform talc Asbestiform talc is 280 Figure 1.1 Schematic structure of talc IARC MONGRAPHS VOLUME 93 From NIMSoffice http://en.wikipedia.org/wiki/File:Talc.GIF TALC 281 formed when talc plates elongate parallel to the a axis within the plate to form true ribbon fibres of talc These fibres may occur in an asbestiform habit consisting of bundles of narrow fibres randomly oriented around the axis of elongation c axis In some deposits including those in the Gouverneur District of New York State a small proportion of tale fibres are intergrown on a nanoscale with amphiboles Stemple & Brindley 1960 Greenwood 1998 Wylie et al 1997 Chemical composition The ideal formula is Mg3Si4010 When expressed in the standard oxide form the ideal chemical composition is 31.9 MgO 63.4 SiO2 and 4.8 H POiniazkiewicz et al 1994 No talc is ideal and small amounts of aluminium and iron are common impurities Aluminium may substitute for both magnesium and silicon iron and iron may substitute for magnesium Tale that has almost all magnesium substituted by iron is called minnesotaite and is abundant in the iron formations of Minnesota USA Deer et al 1962 Fluorine is the most common substitution for the hydroxy group Petit 2005 Small amounts of nickel chromium calcium potassium sodium and manganese are also found in the octahedral sites while titanium may substitute for silicon in the tetrahedral site Table 1.2 provides examples of the variability in the composition of mineral talcs talc ores and talc products Solubility The solubility of talc has been described in detail by Jurinski and Rimstidt 2001 On the sole basis of dissolution under pulmonary conditions authors estimated that the maximum residence time in the lung of a um spherical particle of talc is approximately 8 years The reader is referred to Section 4 for a detailed description of the kinetics of deposition and clearance 1.1.4 Chemical and mineralogical characteristics of talc deposits Talc ore deposits are formed from the hydrothermal metasomatism of existing rocks by fluids that contain silicon and magnesium Hydrothermal fluids may be derived from fluids that migrate during retrograde or prograde regional metamorphism or from contact metamorphism that is associated with nearby or distant intrusive igneous rocks The chemical composition of talc and its associated minerals result from the original rock type the nature of the hydrothermal alteration and metamorphic history Harben & Kuzvart 1996 The chemical and mineral compositions of talc from various locations are shown in Tables 1.2 and 1.3 respectively a Talc derivedfrom mafic and ultramafic rocks Talc deposits the protoliths of which are ultramafic or mafic rocks are abundant in number but small in total production They are found in discontinuous bodies in orogenic belts such as the Alps the Appalachians and the Himalayas and form during the regional metamorphism that accompanies orogenesis They also occur in Canada Ontario and Quebec Egypt Finland Germany Norway the Russian Federation Shabry and Miassy 282 Table 1.2 Chemical composition wt of selected mineral tales tale ores and tale mineral products Component Mineral talc" Talc ores I 2 3 4 5 6 7 8 9

Garth Wyllie, executive director of the Cosmetic Toiletry & Fragrance Association of New Zealand, Aug. 24 told Bloomberg BNA that his organization fully supported the ban, although the earlier start date was "a little surprising."

k i n t 1 ai^ Ta repeatedly'Publlshed author in the peer-reviewed literature, including a book chapter on Naturally Occurring Asbestos (NOA) for ASTM International (ASTM) as well as articles on the science of asbestos, talc (including cosmetics), geology, and mineralogy, nd have given numerous asbestos-related presentations to various organizations, including the Environmental Information Association (EIA) (formerly the National Asbestos Council) the American Industrial Hygienist Association (AIHA), and ASTM

k i n t 1 ai^ Ta repeatedly'Publlshed author in the peer-reviewed literature, including a book chapter on Naturally Occurring Asbestos (NOA) for ASTM International (ASTM) as well as articles on the science of asbestos, talc (including cosmetics), geology, and mineralogy, nd have given numerous asbestos-related presentations to various organizations, including the Environmental Information Association (EIA) (formerly the National Asbestos Council) the American Industrial Hygienist Association (AIHA), and ASTM

Talcum powder is cosmetic-grade talc (Zazenski et a l, 1995).

FILE NAME: Johnson & Johnson (JAJ) DATE: 2017 Aug 18 DOC#: JAJ019 DOCUMENT DESCRIPTION: Legal - Deposition of Dr.

FILE NAME: Johnson & Johnson (JAJ) DATE: 2017 Aug 15 DOC#: JAJ016 DOCUMENT DESCRIPTION: Legal - Deposition of Dr.

FILE NAME: Johnson & Johnson (JAJ) DATE: 2017 Aug 16 DOC#: JAJ017 DOCUMENT DESCRIPTION: Legal - Deposition of Dr.