Document JJYwmXL6YKJq3kkmpwGZOVd2v

ONTARIODSESEOTIEik KXJNDATION SHEfllDAN PARK RESEARCH COMMUNITV MISSISSAUGA. ONTARIO CANAOA LSK tB3 14161 822-4111 . TELEX 06 M?311 DEPARTMENT OF MATERIALS CHEMISTRY Non-Metallic Minerals Section THE PHYSIOLOGICAL EFFECTS OF GYPSUM Information Services Report No. IS 3-76-1 W. D. Brown February 8, 1977 (Rev. for The Gypsum Association Suite 1210 1603 Orrington Avenue Evanston, Illinois 60201 U.S.A. Attention: Mr. Fred Rogers, Director Administrative Services PLAINTIFF'S EXHIBIT GP-138J SGP 0008902 TIMS REPORT RELATES ONlT TO THE PARTICULAR INSTRUMENT MATERIAL OR OTHER SURJECT REFERRED TO IN IT NO RERRESENTATION IS MAOE THAT SIMILAR ARTICLES WILL M or LIRE OUALITT. WITHOUT THI TRIOR WRITTEN CONSENT OF THE ONTARIO RESEARCH FOUNOATION NO PURUCATION IN WHOLE OR IN FART OF THE TE>T OR SUSSTANCE Of this KRORT SHALL IE MADE NOR SHALL THENAMEOFTHE ONTARIO RESEARCH FOUNDA'ION RE USEO IN ANT WA 'N CONNECTION WITH THE SALE OFFERING OR ADVERTISING OF ANV ARTICLE OR PRODUCT ANV *<S*'NG in SMC TION OR inv IS'iGA'ION OF t,,E ins'R'JMENTS ma'CNiacs OR OThER SUR.'ECTS MRFORMEO RT ONTaR o PeSKRCh f O'JNOA "ON i". CCONDUCTEO IN ACCORDANCE with the REST TECHNICAL STANDARDS IT'hi ONT ARIO REST ARCH FOUNDATION RUT NEITHER IT NOR ITS EMFLOTICS SHALL RE RESPONSES FOR A.V hl HR H.M.r.r Rr Till TIN!'. niRfr T| v HR INOlNFTTl V F ROM ANT OFFAULT FRROR OR OMISSION IS 3-76-1 -1- 1. INTRODUCTION The mining Enforcement Safety Administration (MESA) has recently proposed new regulations concerning occupational exposure to mineral fibers. These proposed regulations would essentially classify a wide range of mineral fibers, including gypsum, into the same category as asbestos. At the request of the Gypsum Association, ORF has conducted a prelim inary literature survey of any studies carried out to determine the physio logical effects of gypsum. The two studies described in this report are the only known reported studies in which fibrous gypsum was used. Other studies have been made using non-fibrous gypsum since most of the gypsum utilized by gypsum product manufacturers is of the non-fibrous type. These studies are not covered in this report, but they support the position that gypsum is soluble in the body. 2. SUMMARY A survey of the literature showed that there are only two publications concerned with the injection of fibrous gypsum into animals. Both of these publications were by Friedrichs who reported the absence of tumors in one paper, while in the other, the presence of 5% tumors was reported. This level is considerably below the level of tumors produced by chrysotile, glass fibers, and nemolite. In addition to published work, the opinion of several medical experts actively involved in animal studies was obtained. The general opinion was that because of the high solubility of gypsum, tumors would not be expected to be produced by this material. One particular study carried out by Birchall using fibrous calcium carbonate in the aragonite phase, showed that this material behaved as an inert dust. Birchall felt that gypsum would give a similar response. SGP 0008903 IS 3-76-1 -2- 3. RESULTS OF SURVEY 3.1 Animal Studies In 1972, an article by F. Pitt and K.-H. Friedrichs-^ ^ (Medizinisches Institut fiir Lufthygiene und Silikoseforschung, Universitat Dusseldorf, Dtisseldorf, Federal Republic of Germany) appeared in Naturwissenschaften 59:318. Animals were injected with dusts of various materials. Including some in the fibrous form. The animals were examined after 530 days' exposure, and in the case of gypsum, no tumors were found. Dr. Friedrichs, at the I0EH Conference held in Montreal, October 29, 30, 1973, (2) repeated these findings, as follows. In the following experiments we used a series of fibers which were of different chemical composition. For example, chrysotlle, glass, nemalite, fibrous gypsum and pectolite. And on the other hand, dusts which had similar chemical composition but no fibrous structure; for example, brucite, and talcum and biotlte. After a time of 530 days, we only found tumors in rats which were injected with chrysotile, glass and nemalite. However, a December 1974 article by F. Pott, F. Huth and K.-H. Friedrichs (3) contained the following information. Fibrous dusts (chrysotile, glass fibers, nemalite, palygorscite, and gypsum) and granular dusts (actlnolite, biotite, hematite, pectolite, sanidlne, and talcum) were injected intraperitoneally into rats. The fibrous dusts (other than gypsum) resulted in a high incidence of mesothelioma (30 - 67X). Gypsum produced only 5% and granular dusts none at all. Dr. Mearl F. Stanton of the National Cancer Institute, Bethesda, Maryland, said that he has Injected three different types of gypsum into the pleural cavity of rats, although none of the types was conspicuously SGP 0008904 IS 3-76-1 - 3- fibrous. So far as he was able to recall, none of the types had any significant effect on the host tissue. Dr. J. D. Birchall of Imperial Chemical Industries Limited, Mond Division, Cheshire, England, provided a similar opinion in a letter to the undersigned dated 2 September, 1976. Dr. Birchall said that he is unaware of any work on gypsum itself, but experiments have been done at ICI on a fibrous form of calcium carbonate in the aragonite phase. These were crystals in the size range of 1-2 p diameter and 10-100 p in length, with an average length of 30 p. In in vitro tests using macrophages incubated with the dust, followed by examination for the proportion of dead cells, fibrous calcium carbonate behaved as an inert dust and in no way different from normal equidimensional calcium carbonate crystals. (In this particular test, high levels of cell death are normally associated with a fibrotic response in lung tissue.) Dr. Birchall felt that gypsum would give a similar response. 3.3 Literature Search The following entries were found in Dangerous Properties of Industrial Materials by N. Irving Sax, Third Edition, 1968. (A) Sulphate Toxicity: Variable. In general the toxic qualities of substances containing the sulphate radical is that of the material (cation) with which the sulphate is combined. Calcium Sulphate (pure anhydrous) Toxic Hazard Rating: Unknown; a nutrient and/or dietary supplement food additive. According to the definitions section of this publication, the designation "unknown" is given to substances which fall into one of the following categories: SGP 0008905 IS 3-76-1 4 (a) No toxicity information could be found in the literature and none was known to the authors. (b) Limited information based on animal experiments was available but in the opinion of the authors this information could not be applied to human exposures. (c) Published toxicity data were felt by the authors to be of questionable validity. In reference to the use of substances as food additives, the book makes the following statement. In the implementation of the food additives law the term "safe" means that there is reasonable certainty among qualified scientists that no harm will result from its use. It is not required to prove beyond any possible doubt that the additive is safe under all conceivable circumstances of use or misuse. The Encyclopedia of Occupational Health and Safety^^ contained the following entry under "Gypsum". Workers employed in the processing of gypsum rock may be exposed to high atmospheric concentrations of gypsum dust (especially during crushing, grinding, etc.), furnace gases and smoke. In gypsum calcining, workers are exposed to high environmental temperatures, and there is also the hazard of burns. Crushing, grinding, conveying and packaging equipment presents a danger of machinery accidents. Gypsum dust has an Irritant action on the mucous membranes of the respiratory tract and eyes, and there have been reports of conjunctivitis, chronic rhinitis, laryngitis, pharyngitis, impaired sense of smell and taste, bleeding from the nose and reactions of SGP 0008906 IS 3-76-1 -5- the tracheal and bronchial membranes in exposed workers. Exper imental animals exposed to gypsum dust developed pneumonia and interstitial pneumosclerosis, and blood and lymph circulation dis orders occurred in the lungs. Dust formation in gypsum processing should be controlled by mechan isation of dusty operations (crushing, loading, conveying, etc.), addition of up to 22 by volume of water to gypsum prior to crushing, use of pneumatic conveyors with covers and dust traps, enclosure of dust sources and provision of exhaust systems for kiln openings and for conveyor transfer points. Good housekeeping and maintenance are essential in preventing the accumulation of deposited dust, and it is advisable, in the workshops containing the calcining kilns, to face the walls and floors with smooth materials to facilitate cleaning. Hot piping, kiln walls, drier enclosures, etc. should be lagged to reduce the danger of burns and to limit heat radiation to the work environment. Workers should wear close-fitting working clothes of dust-tight material and, where necessary, should be supplied with respiratory protective equipment and goggles. It is advisable for gypsum and gypsum-products workers to receive a pre-employment examination followed by periodic examinations each year. 3.4 Computer Search A computer search was done employing the TOXLINE file (U.S. National Library of Medicine) as follows: Key Words (gypsum or (calcium sulphate (calcium sulfate (physiolog; (toxic: and 1, 2 (1) (2) SGP 0008907 IS 3-76-1 -6- Of the title citations, two were judged to have possible relevance. One of these was a Russian article without an English abstract, titled Standardization of Gypsum Mineral Dust and the second a German article (Einbrodt, H. J.: Threshhold Values for Dust-like Air Pollutants and other Anti-pollution Measures) with an abstract containing the following relevant information. A preliminary four-group classification is proposed; acutely toxic dusts (As, asbestos. Be, Ca, Hexavalent Cr compounds); dangerous dusts (Ba, I, Te, aluminum carbide, CaO, basalt); dusts dangerous for some persons (Mn, Mo, aluminum carbide, etc.) and generally inert dusts such as gypsum, iron oxide, dolomite, etc. Proposed limiting values for these categories ranged from 20-150 mg/m3. A search was also made of the CANCERLINE file (MEDLINE data base) using identical key words and commands to the above. No relevant data were retrieved from this source. 3.5 Literature Search at the Institute of Occupational and Environmental Health A literature search was carried out at the Institute of Occupational and Environmental Health in Montreal, Quebec, at the invitation of Dr. Premysl V. Pelnar. Four references were found, photocopies of which are attached. 3.6 Solubilities (From the Handbook of Chemistry and Physics, 57th Edition; 1976-1977) Gypsum (CaS042H20) Calcium Carbonate (CaC03) (aragonite phase) Solubilities in Grams per 100 cm3 Cold Water Hot Water 0.241 (0C) 0.222 (100C) 0.00153 (25C) 0.00190 (75C) SGP 0008908 IS 3-76-1 -7- 4. CONCLUSIONS Only two papers have been published which describe specific studies of the Injection of fibrous gypsum into animals. These two papers appear to be contradictory concerning whether tumors are formed or not. In the case where tumors were formed, the number of tumors was considerably smaller than the number observed for chrysocile asbestos, glass fiber and nemalite. In addition, the overwhelming opinion of several medical people widely recognized as expert in the field of animal studies is that tumors would not be expected to occur with fibrous or non-flbrous gypsum because of the high solubility of this material. Other studies, not covered in this report, deal with the effect of non-fibrous gypsum and support the position that gypsum is soluble in the body. This is significant because most of the gypsum utilized by gypsum product manufacturers is of the non-fibrous type. With one exception, all of the evidence and medical opinion suggests that the physiological effect cf fibrous gypsum is similar to that for a non-fibrous gypsum dust. WDB:pmt -''W. D. Brown Technologist III Department of Materials Chemistry SGP 0008909 REFERENCES 1. Pott, F. and Friedrichs, K.-H.: Tumors in rats after intraperitoneal Injection of fibrous dusts (German), Naturvissenschaften 59:318, 1972. 2. Reported in Fibres for biological experiments, edited by Dr. Premysl V. Pelnar; transcript of the Institute of Occupational and Environmental Health Conference, held in Montreal, Quebec, 29, 30 October, 1973. 3. Pott, F., Huth, F., and Friedrichs, K.-H.: Tumorigenic effect of fibrous dusts in experimental animals. Environmental health perspectives, Vol. 9, pp 313-315, 1974. 4. Sax, N. Irving: Dangerous properties of Industrial materials. Third Edition, 1968; Pub. Reinhold Book Corporation. 5. Encyclopedia of occupational health and safety. Pub. International Labour Office, Geneva. SGP 0008910 IS 3-76-1 9 APPENDIX Information Sources The following provided the names of researchers who had conducted investigations into the physiological effects of fibrous materials. Dr. P. V. Pelnar Institute of Occupational and Environmental Health Montreal, Quebec The following replied that they were unaware of any work that had been done on the physiological effects of fibrous gypsum. They are listed in the order in which they were contacted. Mr. A. A. Winer Department of Energy, Mines and Resources Ottawa, Ontario Chairman of the E-34 Naturally Occurring Inorganic Fibres Task Force Mr. Marcel Cossette Director of the Quebec Asbestos Mining Association Testing Research Laboratory University of Sherbrooke Sherbrooke, Quebec Dr. William Nicholson Department of Community Medicine Mount Sinai School of Medicine New York, N.Y. The following expressed opinions on the physiological effects of gypsum, without personally having done any work with the compound. Dr. J. D. Birchall Imperial Chemical Industries Mond Division Runcorn, Cheshire England SGP 0008911 IS 3-76-1 - 10 - The following stated that they had done animal implants with gypsum. Dr. Mearl F. Stanton National Cancer Institute Bethesda, Maryland From the literature: Dr. Karl-Heinz Friedrichs Medizinisches Institut fur Lufthygiene und Silikoseforschung Universitat Dusseldorf Dtisseldorf Federal Republic of Germany The literature sources are contained In the Reference section. 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