Refractory ceramic fibers: Fiber characteristics, potential health effects and clinical observations.

Refractory ceramic fibers (RCFs) are amorphous fibers that belong to a class of materials termed synthetic vitreous fibers (SVFs), also called man-made mineral fibers (MMMFs), which includes alkaline earth silicate wool, glass wool, rock (stone) wool, slag wool, and special-purpose glass fibers. RCFs are more durable and biopersistent than several other SVFs, although very much less biopersistent than either amosite or crocidolite asbestos. Chronic inhalation studies indicated that rats and hamsters exposed to RCF fibers developed fibrosis and tumors. Epidemiological studies at the University of Cincinnati funded by the Industry indicated that exposed workers; (1) exhibited symptoms (e.g., dyspnea) similar to those reported in other dust-exposed populations, (2) developed statistically, but not clinically, significant deficits in certain measures of pulmonary function in a cross sectional study, but no excessive decline in a longitudinal study, and (3) a dose related increase in pleural plaques, but no interstitial fibrosis. The 2003 mortality study indicated no incremental lung cancer and no cases of mesothelioma. RCF producers developed a comprehensive industry wide product stewardship program (PSP) beginning in the late 1980s. In conjunction with the PSP, there has been a progressive decrease in the TWA concentration of fibers by manufacturers and end-users. The research program has successfully produced more soluble fibers and undertaken efforts to develop larger diameter fibers. The results of the ongoing epidemiology studies confirm that occupational exposure to RCF is associated with the development of pleural plaques and minor decrements in lung function, but no interstitial fibrosis or incremental lung cancer.

Review of refractory ceramic fiber (RCF) toxicity, epidemiology and occupational exposure.

This literature review on refractory ceramic fibers (RCF) summarizes relevant information on manufacturing, processing, applications, occupational exposure, toxicology and epidemiology studies. Rodent toxicology studies conducted in the 1980s showed that RCF caused fibrosis, lung cancer and mesothelioma. Interpretation of these studies was difficult for various reasons (e.g. overload in chronic inhalation bioassays), but spurred the development of a comprehensive product stewardship program under EPA and later OSHA oversight. Epidemiology studies (both morbidity and mortality) were undertaken to learn more about possible health effects resulting from occupational exposure. No chronic animal bioassay studies on RCF have been conducted since the 1980s. The results of the ongoing epidemiology studies confirm that occupational exposure to RCF is associated with the development of pleural plaques and minor decrements in lung function, but no interstitial fibrosis or incremental lung cancer. Evidence supporting a finding that urinary tumors are associated with RCF exposure remains, but is weaker. One reported, but unconfirmed, mesothelioma was found in an individual with prior occupational asbestos exposure. An elevated SMR for leukemia was found, but was absent in the highly exposed group and has not been observed in studies of other mineral fibers. The industry will continue the product stewardship program including the mortality study.

Bentonite toxicology and epidemiology - a review.

Bentonite, a clay with numerous industrial and consumer applications, is mined and processed in many countries of the world. Its many beneficial uses also create the potential for widespread occupational and consumer exposure. The available studies on toxicity and epidemiology indicate that the principal exposure pathway of concern is inhalation of respirable dust by occupationally exposed cohorts. Bentonite itself is probably not more toxic than any other particulate not otherwise regulated and is not classified as a carcinogen by any regulatory or advisory body, but some bentonite may contain variable amounts of respirable crystalline silica, a recognized human carcinogen. Therefore, prudent management and adherence to occupational exposure limits is appropriate. This review summarizes the literature available on production, applications, exposure, toxicity, and epidemiology of bentonite and identifies data gaps and limitations.

Are pleural plaques an appropriate endpoint for risk analyses?

This review summarizes the literature on the relation between the development of pleural plaques and non-malignant and malignant disease in cohorts exposed to asbestos and other fibers. The available evidence indicates that, absent any other pleural disease, the presence of pleural plaques does not result in respiratory symptoms or clinically significant impacts on lung function. For certain types of asbestos, the development of pleural plaques is statistically correlated with malignant disease, but the evidence is consistent with the hypothesis that pleural plaques without other pleural disease are a marker of exposure, rather than an independent risk factor. Pleural plaques have also developed in cohorts exposed to other fibers that have not proven to be carcinogenic. Risk analyses should be based on the avoidance of known adverse conditions, rather than pleural plaques per se.

Perspectives on refractory ceramic fiber (RCF) carcinogenicity: comparisons with other fibers.

In 2011, SCOEL classified RCF as a secondary genotoxic carcinogen and supported a practical threshold. Inflammation was considered the predominant manifestation of RCF toxicity. Intrapleural and intraperitoneal implantation induced mesotheliomas and sarcomas in laboratory animals. Chronic nose-only inhalation bioassays indicated that RCF exposure in rats increased the incidence of lung cancer and similar exposures resulted in mesothelioma in hamsters, but these studies may have been compromised by overload. Epidemiological studies in the US and Europe showed an association between exposure and prevalence of respiratory symptoms and pleural plaques, but no interstitial fibrosis, mesotheliomas, or increased numbers of lung tumors were observed. As the latency of asbestos induced mesotheliomas can be up to 50 years, the relationship between RCF exposure and respiratory malignances has not been fully determined. Nonetheless, it is possible to offer useful perspectives. RCF and rock wool have similar airborne fiber dimensions and biopersistence. Therefore, it is likely that these fibers have similar toxicology. Traditional rock wool has been the subject of numerous cohort and case control studies. For rock wool, IARC (2002) concluded that the epidemiological studies did not provide evidence of carcinogenicity. Based on analogies with rock wool (read across), it is reasonable to believe that increases in lung cancer or any mesotheliomas are unlikely to be found in the RCF-exposed cohort. RCF producers have developed a product stewardship program to measure and control fiber concentrations and to further understand the health status of their workers.

Screening tests: a review with examples.

Screening tests are widely used in medicine to assess the likelihood that members of a defined population have a particular disease. This article presents an overview of such tests including the definitions of key technical (sensitivity and specificity) and population characteristics necessary to assess the benefits and limitations of such tests. Several examples are used to illustrate calculations, including the characteristics of low dose computed tomography as a lung cancer screen, choice of an optimal PSA cutoff and selection of the population to undergo mammography. The importance of careful consideration of the consequences of both false positives and negatives is highlighted. Receiver operating characteristic curves are explained as is the need to carefully select the population group to be tested.

Perlite toxicology and epidemiology--a review.

Perlite is a generic name for an amorphous volcanic alumina-silicate rock that expands by a factor of 4-20 when rapidly heated to 1400-1800 °F (760-980 °C). Both the ore and the expanded product have extensive and widespread commercial applications. Limited data on the toxicology of perlite in animal studies indicate that the LD50 (oral ingestion) is more than 10 g/kg and, from a chronic inhalation study in guinea pigs and rats, that the NOAEL for the inhalation pathway is 226 mg/m³. Health surveillance studies of workers in US perlite mines and expansion plants (including some workers exposed to levels greater than prevailing occupational exposure limits (OELs) conducted over 20 years indicate that the respiratory health of workers is not adversely affected. Studies in Turkish mines and expanding plants had generally similar results, but are more difficult to interpret because of high smoking rates in these populations. A recent mortality study of permanent residents of the island of Milos (Greece) exposed to various mining dusts (including perlite) resulted in non-significant increases in standard mortality ratios for pneumonia and chronic obstructive pulmonary disease (COPD), whereas a companion morbidity study revealed elevated odds ratios for allergic rhinitis, pneumonia, and COPD when compared to another industrial area of Greece. Residents were exposed to other mining dusts and other possible causes or contributing factors and no ambient monitoring data were presented so it is not possible to use this study for risk calculations of perlite-exposed populations. Perlite is regulated as a "nuisance dust" in most countries.

Wollastonite toxicity: an update.

This review updates earlier work addressing the epidemiology and toxicity of wollastonite. Earlier chronic animal bioassay and human mortality data were inadequate (IARC term) or negative and no new studies of these types have been published. Wollastonite has been determined to have low biopersistence in both in vivo and in vitro studies, which probably accounts for its relative lack of toxicity. Earlier morbidity studies of mining/mineral processing facilities in Finland and New York State indicated that exposure to wollastonite might result in pleural plaques (Finland) or decrements in certain measures of lung function (New York). More recent analysis of data from an ongoing health surveillance program at one facility (New York) indicates that there are no pleural plaques or interstitial lung disease or decrements in lung function among never smokers or former smokers occupationally exposed to wollastonite. This result probably reflects continued reduction in exposures as part of an ongoing product stewardship program at this facility and suggests that wollastonite has relatively low toxicity as currently managed.

Are airborne refractory ceramic fibers similar to asbestos in their carcinogenicity?

BACKGROUND: Animal studies on refractory ceramic fiber (RCF) have led to the suggestion that RCF might resemble asbestos in carcinogenicity. Human data are available to test this hypothesis. METHODS: We compared the occurrence of lung cancer and mesothelioma in 605 men engaged in the manufacture of RCF and followed since 1987 to cancer rates that would have been anticipated if airborne RCF were carcinogenic to the same degree as are crocidolite, amosite or chrysotile asbestos. We integrated the results of workplace exposure monitoring with mortality follow-up using formulas presented by Hodgson and Darnton (2000) to estimate hypothesized risks under different asbestos scenarios. RESULTS: During 15,281 person-years of observation, there were 12 deaths from lung cancer. General population rates predicted 11.8 cases expected for an observed/expected (O/E) ratio of 1.0. Anticipated numbers of deaths from lung cancer under hypotheses of carcinogenicity similar to that of amphiboles and chrysotile were 62 and 17, allowing for rejection of amphibole-like effects (p < 10(-5)) but not chrysotile-like carcinogenicity (p = 0.15). There were no cases of mesothelioma, as compared to 4.9 anticipated under a crocidolite-like hypothesis (p = 0.007 to reject), 1.0 for amosite (p = 0.38) and 0.05 for chrysotile (p = 0.95). CONCLUSION: There was no increase in lung cancer or mesothelioma in these workers exposed to RCF. If the cohort had the same exposure to crocidolite asbestos the number of lung cancer and mesothelioma cases would have been significantly greater than observed. The data do not yet permit a similar conclusion with respect to chrysotile asbestos.

Effect of oxidation and extent of oxidation on biologically active PACs in asphalt products.

Recent studies have reported divergent results in rodent cancer assays using fume condensates from a variety of asphalt products. This paper presents results of a study investigating the role of oxidation, or extent of oxidation, on these findings. Five straight run asphalts, made from widely used crude oils, were used as inputs to both production scale and laboratory oxidation units and processed to a range of softening points used in common roofing products. For each of the five asphalts studied, the oxidation reaction significantly decreased measures of polycyclic aromatic compounds (PACs) that have been linked, previously and in analyses included in this study, to tumor induction in rodent bioassays. Mutagenicity index determined by the modified Ames assay was reduced between 41% and 50% from the input asphalt to the final oxidized product. A fluorescence method tuned to a subset of PAC compounds that have been associated with carcinogenic behavior in mouse bioassays was reduced between 39% and 71%. The decrease was largest in the first quarter of the oxidation reaction. These findings indicate that oxidation, by itself, was not a likely factor in the tumor induction seen in the previous studies. Rather, other factors such as the conditions of fume generation and crude source (coupled with possible differences in distillation endpoints) were more likely to have determined the outcomes. Analyses of previously published data, presented in this paper, suggest that the modified Ames and fluorescence assays are valuable screening tools for use in future health-related asphalt research.

Quantitative exposure matrix for asphalt fume, total particulate matter, and respirable crystalline silica among roofing and asphalt manufacturing workers.

This paper summarizes available data on worker exposures to asphalt fume (soluble fraction), total particulate matter, and respirable crystalline silica (quartz) [hereinafter RCS] over a 30-year period in Owens Corning's asphalt production and roofing manufacturing plants. For the period 1977 through 2006, the air-monitoring database contains more than 1,400 personal samples for asphalt fume (soluble fraction), 2,400 personal samples for total particulate, and 1,300 personal samples for RCS. Unique process-job categories were identified for the asphalt production and roofing shingle manufacturing plants. Quantitative exposures were tabulated by agent, process-job, and calendar period to form an exposure matrix for use in subsequent epidemiologic studies of the respiratory health of these workers. Analysis of time trends in exposure data shows substantial and statistically significant exposure reductions for asphalt fume (soluble fraction), total particulate matter, and respirable crystalline silica at Owens Corning plants. Cumulative distribution plots for the most recent sampling period (2001-2006) show that 95% of the asphalt fume (soluble fraction) measurements were less than 0.25 mg/m3; 95% of the total particulate measurements were less than 2.2 mg/m3; and 95% of the RCS measurements were less than 0.05 mg/m3. Several recommendations are offered to improve the design of future monitoring efforts.

Refractory ceramic fiber (RCF) toxicity and epidemiology: a review.

This paper provides a review of the relevant literature on refractory ceramic fibers (RCFs), summarizing relevant data and information on the manufacture, processing, applications, potential occupational exposure, toxicology, epidemiology, risk analysis, and risk management. RCFs are amorphous fibers used for high-temperature insulation applications. RCFs are less durable/biopersistent than amphibole asbestos, but more durable/biopersistent than many other synthetic vitreous fibers (SVFs). Moreover, as produced/used, some RCFs are respirable. Toxicology studies with rodents using various exposure methods have shown that RCFs can cause fibrosis, lung cancer, and mesothelioma. Interpretation of these animal studies is difficult for various reasons (e.g., overload in chronic inhalation bioassays). Epidemiological studies of occupationally exposed cohorts in Europe and the United States have demonstrated measurable effects (e.g., mild respiratory symptoms and pleural plaques) but no disease (i.e., no interstitial fibrosis, no excess lung cancer, and no mesothelioma) to date. The RCF industry, working cooperatively with various government agencies in the United States, has developed a comprehensive product stewardship program (PSP) to identify and control risks associated with occupational exposure. One provision of the PSP is the adoption of a voluntary recommended exposure guideline (REG) of 0.5 fibers/milliliter (f/ml). Selected on the basis of prudence and demonstrated feasibility, compliance with the REG should reduce risks to levels between 0.073/1000 and 1.2/1000, based on extrapolations from chronic animal inhalation studies.

Product stewardship in wollastonite production.

In July 2002, NYCO Minerals, Inc., discovered a heretofore unknown contaminant in its wollastonite ore. The contaminant was first believed to be tremolite asbestos. Immediate efforts were made to eliminate this material. Additional studies were initiated to fully characterize the contaminant and its distribution in the ore body. Subsequent study by NYCO and their consultants led to the identification of the contaminant as a transition material (TM) intermediate between tremolite and talc. In vitro dissolution rate measurements indicated that the TM dissolved much more rapidly than tremolite asbestos. This article provides background information on wollastonite mineralogy and NYCO's product stewardship program (PSP). At present, NYCO Minerals uses selective mining to control the trace levels of TM in the ore and finished product verified by periodic monitoring of workplace air and finished product.

Workplace monitoring of occupational exposure to refractory ceramic fiber--a 17-year retrospective.

This article presents a 17-year (1990-2006) retrospective summary of ongoing studies of occupational exposure to refractory ceramic fiber (RCF) in the United States. Beginning in 1990, RCF producers integrated and harmonized individual workplace monitoring programs to provide data useful for various longitudinal and cross-sectional analyses, benchmarking, and various technical analyses. For 10 of these 17 years, the program has been conducted in partnership with government agencies, first a 5-year (1993-1998) program with the U.S. Environmental Protection Agency and later another 5-year (2002-2006) program with the Occupational Safety and Health Administration and the National Institute for Occupational Safety and Health. This article updates earlier published studies and provides lessons to be learned in the design of industrial hygiene monitoring and control programs.

Horizontal diffusion elutriation: a new size-separation technique for preparation of rodent-respirable fibers for animal testing.

Short-and long-term animal experiments are used to examine the toxicology and biopersistence of various types of fibers. In order to ensure an adequate exposure dose for testing, modern experimental protocols specify that the exposure aerosol (in an inhalation test) or the fibers (in an intratracheal instillation [IT] test) must contain at least a minimum concentration of long (> 20 mum) rodent-respirable fibers. As produced and handled, most fibers contain a distribution of diameters and lengths, only some of which are both long and rodent-respirable. Therefore, it is necessary to size-separate the fibers to enrich the proportion of long, rodent-respirable fibers in the material to be tested. This article presents a new and relatively simple method for size separation that avoids some of the difficulties associated with other methods. The method, termed horizontal diffusion elutriation (HDE), is illustrated by size-separating refractory ceramic fiber (RCF) and four polycrystalline alumina (PCA) fibers.

The role of fiber durability/biopersistence of silica-based synthetic vitreous fibers and their influence on toxicology.

This work summarizes what is known about the role of fiber durability/biopersistence of silica-based synthetic vitreous fibers (SVFs) and their influence on toxicology. The article describes the key processes leading from exposure to biological effect, including exposure, pulmonary deposition, clearance by various mechanisms, accumulation in the lung, and finally possible biological effects. The dose-dimension-durability paradigm is used to explain the key determinants of SVF toxicology. In particular, the key role played by the durability/biopersistence of long (>20microm) fibers is highlighted. Relevant literature on the prediction of in-vitro dissolution rates from chemical composition is summarized. Data from in-vitro and in-vivo durability/biopersistence tests show that these measures are highly correlated for long fibers. Both durability and biopersistence are correlated with the outcome of chronic inhalation bioassays. A schematic approach is presented for the design and testing of new SVFs with lower biopersistence.

Occupational exposure to carbon/coke fibers in plants that produce green or calcined petroleum coke and potential health effects: 1. Fiber characteristics.

Carbon/coke fibers are found in bulk samples of calcined petroleum coke. Carbon/coke and other fibers, including calcium silicate, cellulose, gypsum, and iron silicate, have been found in exposure monitoring of workers who make or handle green or calcined petroleum coke. Carbon/coke fibers are not classified or regulated as carcinogens by any agency, and the available literature (summarized in this article) has not reported significant adverse health effects associated with exposure to these fibers or dusts containing these fibers. However, available epidemiological and toxicological studies have limitations that prevent a definitive assessment of carbon/coke fiber toxicity. Therefore, it is prudent to monitor and control workplace concentrations. Analyses by transmission electron microscopy (TEM) indicate that the carbon/coke fibers are amorphous, irregularly shaped, and generally rather short (94% less than 20 microm long). Nearly all carbon/ coke fibers satisfying NIOSH 7400 B counting criteria are detectable by phase-contrast optical microscopy (PCOM), which permits the use of a highly efficient sequential sampling strategy for analysis. Data are presented on the distribution of carbon/coke structure and fiber lengths and diameters. Bootstrap resampling results are presented to determine confidence intervals for structure/fiber length and diameter. Data on time-weighted average concentrations are given in a companion article, but nearly all time-weighted average carbon/coke fiber concentrations were beneath 0.1 fibers per milliliter.

Occupational exposure to carbon/coke fibers in plants that produce green or calcined petroleum coke and potential health effects: 2. Fiber concentrations.

We monitored exposure to various fibers among workers in eight plants operated by ConocoPhillips that produce green or calcined petroleum coke. Carbon/coke and other fibers, including calcium silicate, cellulose, gypsum, and iron silicate, were found in occupational samples. Carbon/coke fibers were found in bulk samples of calcined petroleum coke, the probable source of these fibers in occupational samples. Time-weighted average (TWA) total fiber concentrations were approximately lognormally distributed; 90% were < or = 0.1 f/ml. Although consistently low, TWA total fiber concentrations varied with plant, job (tasks), and type of coke. This was expected given the substantial differences in plant configuration, technology, and workplace practices among refineries and carbon plants. Carbon/coke fibers (identified and measured using transmission electron microscopy [TEM]) were found at all plants producing all types of calcined coke and not detected at any plant producing only green coke. Approximately 98% of all carbon/coke TWAs were < or = 0.1 f/ml. Analysis of task length average (TLA) data by various statistical techniques indicates that the average carbon/coke TLA is certainly < or = 0.05 f/ml and probably < 0.03 f/ml.

A review of the toxicology and epidemiology of wollastonite.

Wollastonite is a naturally occurring calcium silicate (CaSiO(3)) that is produced in both powder and fibrous forms. It is a valuable industrial mineral used in plastics, ceramics, metallurgical applications, paint, and friction products. For some applications wollastonite serves as an asbestos replacement. To varying degrees, wollastonite grades contain respirable particles/fibers, some of which have lengths and diameters that might be biologically active if deposited and retained in the lung. In this review we provide background information on wollastonite properties, markets, production and use, regulatory classification, and occupational exposure limits. We also summarize the available studies on the toxicology and epidemiology of wollastonite. We conclude that there is inadequate evidence for the carcinogenicity of wollastonite in animals and, based on strong evidence that wollastonite is not biopersistent, believe that a well-designed animal inhalation bioassay would have a negative result. The epidemiological evidence for wollastonite is limited, but does not suggest that workers are at significant risk of an increased incidence of pulmonary fibrosis, lung cancer, or mesothelioma. Morbidity studies have demonstrated a nonspecific increase in bronchitis and reduced lung function. It is prudent, however, to continue product stewardship efforts by wollastonite producers to control workplace exposures and to monitor scientific developments.