Translational toxicology in setting occupational exposure limits for dusts and hazard classification - a critical evaluation of a recent approach to translate dust overload findings from rats to humans

Particle and Fibre Toxicology

Volumn 12, Issue 1, 2015, Pages

  Morfeld, Peter ^a,b   Bruch, Joachim ^c,d   Levy, Len ^e   Ngiewih, Yufanyi ^f   Chaudhuri, Ishrat ^g   Muranko, Henry J ^h   Myerson, Ross ^i,j   McCunney, Robert J ^k,l  

^a EVONIK INDUSTRIES AG   (Germany)

^b UNIVERSITY OF COLOGNE   (Germany)

^c UNIVERSITY OF DUISBURG ESSEN   (Germany)

^d IBE GmbH ^*  (Germany)

^e CRANFIELD UNIVERSITY   (United Kingdom)

^f Orion Engineered Carbons GmbH   (Germany)

^g CABOT CORPORATION   (United States)

^h Muranko and Associates   (United States)

ⁱ WASHINGTON HOSPITAL CENTER   (United States)

^j GEORGE WASHINGTON UNIVERSITY   (United States)

^k MASSACHUSETTS INSTITUTE OF TECHNOLOGY   (United States)

^l BRIGHAM AND WOMEN S HOSPITAL   (United States)

more..

Author keywords

GBS; Granular biopersistent dusts; Inflammation; Lung cancer; MAK; OEL; Poorly soluble dusts; Rat overload; Translational toxicology

Indexed keywords

CARBON; CARCINOGEN; COBALT; POLITEF; TITANIUM DIOXIDE; AIR POLLUTANT; DUST;

ANALYTICAL ERROR; ARTICLE; CANCER RISK; CARCINOGENICITY; CHRONIC INFLAMMATION; CLASSIFICATION; COAL MINING; CONCENTRATION (PARAMETERS); DUST; EUROPEAN UNION; EXPERIMENTAL MODEL; HAZARD ASSESSMENT; HEALTH CARE ORGANIZATION; HUMAN; INHALATION; LUNG CANCER; LUNG CLEARANCE; LUNG LAVAGE; LUNG PARENCHYMA; MAXIMUM ALLOWABLE CONCENTRATION; METHODOLOGY; NONHUMAN; OCCUPATIONAL EXPOSURE; PARTICLE SIZE; PRIORITY JOURNAL; RAT; RELIABILITY; REPRODUCIBILITY; RISK ASSESSMENT; SPECIES DIFFERENCE; TOXICITY TESTING; TRANSLATIONAL RESEARCH; UNCERTAINTY; VOLUMETRY; ADVERSE EFFECTS; AIR POLLUTANT; ANALYSIS; ANIMAL; BRONCHOALVEOLAR LAVAGE FLUID; CARCINOGEN TESTING; CHEMICALLY INDUCED; CYTOLOGY; ENDOTRACHEAL INTUBATION; LUNG TUMOR; PATHOLOGY; PREDICTIVE VALUE; PROCEDURES; STANDARDS; THRESHOLD LIMIT VALUE; TOXICITY;

RATTUS;

AIR POLLUTANTS, OCCUPATIONAL; ANIMALS; BRONCHOALVEOLAR LAVAGE FLUID; CARCINOGENICITY TESTS; DUST; HUMANS; INTUBATION, INTRATRACHEAL; LUNG NEOPLASMS; OCCUPATIONAL EXPOSURE; PREDICTIVE VALUE OF TESTS; RATS; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; SPECIES SPECIFICITY; THRESHOLD LIMIT VALUES;

EID: 84928531363     PISSN: None     EISSN: 17438977     Source Type: Journal    
DOI: 10.1186/s12989-015-0079-3     Document Type: Article

References (185)

1. Hughes C, Waters M, Allen D, Obasanjo I. Translational toxicology: a developmental focus for integrated research strategies. BMC Pharmacol Toxicol. 2013;14:51.
2. Seok J, Warren HS, Cuenca AG, Mindrinos MN, Baker HV, Xu W, et al. Genomic responses in mouse models poorly mimic human inflammatory diseases. Proc Natl Acad Sci U S A. 2013;110(9):3507-12.
3. Committee on hazardous substances (AGS). Risk-related concept of measures for activities involving carcinogenic hazardous substances. TRGS 910. GMBl. 2014; 258-70. Available from: http://www.baua.de/de/Themen-von-A-Z/Gefahrstoffe/TRGS/TRGS-910.html. Accessed November 17, 2014.
4. Tran CL, Kuempel ED, Castranova V. A rat lung model of exposure, dose and response to inhaled silica. Ann Occup Hyg. 2002;46(suppl 1):14-7.
5. Brown JS, Wilson WE, Grant LD. Dosimetric comparisons of particle deposition and retention in rats and humans. Inhal Toxicol. 2005;17(7-8):355-85.
6. Kuempel ED, Tran CL, Castranova V, Bailer AJ. Lung dosimetry and risk assessment of nanoparticles: evaluating and extending current models in rats and humans. Inhal Toxicol. 2006;18(10):717-24.
7. SCOEL - The Scientific Committee on Occupational Exposure Limits 2013. Methodology for the derivation of occupational exposure limits. Key documentation (version 7). 2013. Available from: http://ec.europa.eu/social/main.jsp?catId=148&langId=de&intPageId=684. Accessed November 17, 2014.
8. Cullen RT, Tran CL, Buchanan D, Davis JM, Searl A, Jones AD, et al. Inhalation of poorly soluble particles. I. Differences in inflammatory response and clearance during exposure. Inhal Toxicol. 2000;12(12):1089-111.
9. Cherrie JW, Brosseau LM, Hay A, Donaldson K. Low-toxicity dusts: current exposure guidelines are not sufficiently protective. Ann Occup Hyg. 2013;57(6):685-91.
10. Kuempel ED, Attfield MD, Stayner LT, Castranova V. Human and animal evidence supports lower occupational exposure limits for poorly-soluble respirable particles: letter to the editor re: 'Low-toxicity dusts: current exposure guidelines are not sufficiently protective' by cherrie, brosseau, Hay and Donaldson. Ann Occup Hyg. 2014;58(9):1205-8. September 5, 2014.
11. Hartwig A. General threshold limit value for dust (R fraction) (Biopersistent granular dusts) [MAK Value Documentation, 2012]. 2014: Wiley-VCH Verlag GmbH & Co. KGaA. Published Online: 16 April 2014. 9783527600410. Available from: http://onlinelibrary.wiley.com/doi/ 10.1002/3527600418.mb0230stwe5314/pdf. Accessed November 17, 2014.
12. Deutsche Forschungsgemeinschaft. List of MAK and BAT values 2013: Maximum concentrations and biological tolerance values at the workplace. 2013: Wiley-VCH Verlag GmbH & Co. KGaA. Available from: http://onlinelibrary.wiley.com/doi/10.1002/9783527675135.oth1/pdf. Accessed November 17, 2014.
13. SCOEL - The Scientific Committee on Occupational Exposure Limits 2013. The 88th and 90th SCOEL minutes; 2013. Available from: http://ec.europa.eu/social/main.jsp?catId=148&langId=en&intPageId=684. Accessed November 17, 2014.
14. Pauluhn J. Poorly soluble particulates: searching for a unifying denominator of nanoparticles and fine particles for DNEL estimation. Toxicol. 2011;279(1-3):176-88.
15. Greim H, editor. General Threshold Limit Value for Dust. Weinheim: Wiley-VCH; 1997.
16. de Winter R, Cassee FR. From concentration to dose: factors influencing airborne particulate matter deposition in humans and rats. Bilthoven, Netherland 2002. 650010031/2002. 36. Available from: http://rivm.openrepository.com/rivm/bitstream/10029/9272/1/650010031.pdf?origin=publication_detail. Accessed November 17, 2014.
17. Muhle H, Bellmann B, Creutzenberg O, Dasenbrock C, Ernst H, Kilpper R, et al. Pulmonary response to toner upon chronic inhalation exposure in rats. Fundam Appl Toxico. 1991;17(2):280. -299, 827.
18. Oller AR, Oberdorster G. Incorporation of particle size differences between animal studies and human workplace aerosols for deriving exposure limit values. Regul Toxicol Pharmacol. 2010;57(2-3):181-94.
19. Gangwal S, Brown JS, Wang A, Houck KA, Dix DJ, Kavlock RJ, et al. Informing selection of nanomaterial concentrations for ToxCast in vitro testing based on occupational exposure potential. Environ Health Perspect. 2011;119(11):1539-46.
20. Bellmann B, Muhle H, Creutzenberg O, Dasenbrock C, Kilpper R, MacKenzie JC, et al. Lung clearance and retention of toner, utilizing a tracer technique, during chronic inhalation exposure in rats. Fundam Appl Toxicol. 1991;17(2):300-13.
21. U.S. EPA. Air quality criteria for particulate matter (Final report). Washington, DC.;2004. Available from: http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=216546. Accessed November 17, 2014.
22. U.S. EPA. Integrated science assessment for particulate matter (final report). Washington, DC.;2009. 2228. Available from: http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=216546. Accessed August 26, 2014.
23. Yeh HC, Schum GM, Duggan MT. Anatomic models of the tracheobronchial and pulmonary regions of the rat. Anat Rec. 1979;195(3):483-92.
24. Yeh H-C, Schum GM. Models of human lung airways and their application to inhaled particle deposition. Bull Math Biol. 1980;42(3):461-80.
25. Miller FJ, Asgharian B, Schroeter JD, Price O, Corley RA, Einstein DR, et al. Respiratory tract lung geometry and dosimetry model for male Sprague-Dawley rats. Inhal Toxicol. 2014;26(9):524-44.
26. Hsia CC, Hyde DM, Ochs M, Weibel ER. An official research policy statement of the American Thoracic Society/European Respiratory Society: standards for quantitative assessment of lung structure. Am J Respir Crit Care Med. 2010;181(4):394-418.
27. Gehr P, Bachofen M, Weibel ER. The normal human lung: ultrastructure and morphometric estimation of diffusion capacity. Respir Physiol. 1978;32(2):121-40.
28. Stone KC, Mercer RR, Gehr P, Stockstill B, Crapo JD. Allometric relationships of cell numbers and size in the mammalian lung. Am J Respir Cell Mol Biol. 1992;6(2):235-43.
29. Pinkerton KE, Gehr P, Crapo JD. Architecture and Callular Composition of the air-Blood Barrier. In: Parent RA, editor. Comparative Biology of the Normal Lung, Treatise on Pulmonary Toxicology, vol. 1. London: CRC Press Inc; 1992. p. 121-44.
30. EC (European Commission), Joint Research Centre Institute for Health and Consumer Protection (IHCP), EASAC (European Academies Science Advisory Council). Impact on Engineered Nanomaterials on Health: Considerations for Benefit-Risk Assessment. Luxembourg: Publications Office of the European Union. 2011. Available from: http://www.sazu.si/files/file-136.pdf. Accessed November 17, 2014.
31. ICRP (International Commission on Radiological Protection). Human Respiratory Tract Model for Radiological Protection. ICRP Publication 66. Ann. ICRP 24 (1-3). Edinburgh, UK: IOM;1994. Available from: http://www.icrp.org/publication.asp?id=ICRP+Publication+66. Accessed November 17, 2014.
32. Gregoratto D, Bailey MR, Marsh JW. Modelling particle retention in the alveolar-interstitial region of the human lungs. J Radiol Prot. 2010;30(3):491-512.
33. Kuempel ED, O'Flaherty EJ, Stayner LT, Smith RJ, Green FH, Vallyathan V. A biomathematical model of particle clearance and retention in the lungs of coal miners. I. Model development. Regul Toxicol Pharmacol. 2001;34(1):69-87.
34. ECETOC. Poorly soluble particles/lung overload. Brussels, Belgium: European Center for Toxicology and Chemicals; 2013. Available from: http://bit.ly/ecetoc-tr122. Accessed November 17, 2014.
35. Nikula KJ, Vallyathan V, Green FHY, Hahn FF. Influence of exposure concentration or dose on the distribution of particulate material in rat and human lungs. Environ Health Perspect. 2001;109(4):311-8.
36. West GB, Woodruff WH, Brown JH. Allometric scaling of metabolic rate from molecules and mitochondria to cells and mammals. Proc Natl Acad Sci U S A. 2002;99 Suppl 1:2473-24738.
37. Pauluhn J. Repeated inhalation exposure of rats to an anionic high molecular weight polymer aerosol: application of prediction models to better understand pulmonary effects and modes of action. Exp Toxicol Pathol. 2014;66(5-6):243-56.
38. Pauluhn J. Retrospective analysis of 4-week inhalation studies in rats with focus on fate and pulmonary toxicity of two nanosized aluminum oxyhydroxides (boehmite) and pigment-grade iron oxide (magnetite): the key metric of dose is particle mass and not particle surface area. Toxicol. 2009;259(3):140-8.
39. Morrow PE. Possible mechanisms to explain dust overloading of the lungs. Fundam Appl Toxicol. 1988;10(3):369-84.
40. Takezawa J, Miller FJ, O'Neil JJ. Single-breath diffusing capacity and lung volumes in small laboratory mammals. J Appl Physiol. 1980;48(6):1052-9.
41. Ménache MG, Miller FJ, Raabe OG. Particle inhalability curves for humans and small laboratory animals. Ann Occup Hyg. 1995;39(3):317-28.
42. Pauluhn J. The metrics of MWCNT-induced pulmonary inflammation are dependent on the selected testing regimen. Regul Toxicol Pharmacol. 2014;68(3):343-52.
43. Brunauer S, Emmett PH, Teller E. Adsorption of gases in multimolecular layers. J Am Chem Soc. 1938;60:309-18.
44. Tran CL, Buchanan D, Cullen RT, Searl A, Jones AD, Donaldson K. Inhalation of poorly soluble particles. II. Influence Of particle surface area on inflammation and clearance. Inhal Toxicol. 2000;12(12):1113-26.
45. Monteiller C, Tran L, MacNee W, Faux S, Jones A, Miller B, et al. The pro-inflammatory effects of low-toxicity low-solubility particles, nanoparticles and fine particles, on epithelial cells in vitro: the role of surface area. Occup Environ Med. 2007;64(9):609-15.
46. Faux SP, Tran C-L, Miller BG, Jones AD, Monteiller C, Donaldson K. In Vitro Determinants of Particulate Toxicity: The Dose-Metric for Poorly Soluble Dusts. 2003. Available from: http://www.hse.gov.uk/research/rrpdf/rr154.pdf. Accessed November 17, 2014.
47. Oberdörster G, Ferin J, Gelein R, Soderholm SC, Finkelstein J. Role of the alveolar macrophage in lung injury: studies with ultrafine particles. Environ Health Perspect. 1992;97:193-9.
48. Driscoll KE. Role of inflammation in the development of rat lung tumors in response to chronic particle exposure. Inhal Toxicol. 1996;8(Suppl):139-53.
49. Oberdörster G, Ferin J, Lehnert BE. Correlation between particle size, in vivo particle persistence, and lung injury. Environ Health Perspect. 1994;102 Suppl 5:173-9.
50. Bermudez E, Mangum JB, Asgharian B, Wong BA, Reverdy EE, Janszen DB, et al. Long-term pulmonary responses of three laboratory rodent species to subchronic inhalation of pigmentary titanium dioxide particles. Toxicol Sci. 2002;70(1):86-97.
51. Bermudez E, Mangum JB, Wong BA, Asgharian B, Hext PM, Warheit DB, et al. Pulmonary responses of mice, rats, and hamsters to subchronic inhalation of ultrafine titanium dioxide particles. Toxicol Sci. 2004;77(2):347-57.
52. Lison D, Lardot C, Huaux F, Fubini B. Influence of particle surface area on the toxicity of insoluble manganese dioxide dusts. Arch Toxicol. 1997;71(12):725-9.
53. Kuempel ED, Castranova V, Geraci CL, Schulte PA. Development of risk-based nanomaterial groups for occupational exposure control. J Nanopart Res. 2012;14(9):1-15. 2012/08/07.
54. Saber A, Jacobsen N, Mortensen A, Szarek J, Jackson P, Madsen A, et al. Nanotitanium dioxide toxicity in mouse lung is reduced in sanding dust from paint. Part Fibre Toxicol. 2012;9(1):4.
55. Johnston HJ, Hutchison G, Christensen FM, Peters S, Hankin S, Stone V. A review of the in vivo and in vitro toxicity of silver and gold particulates: particle attributes and biological mechanisms responsible for the observed toxicity. Crit Rev Toxicol. 2010;40(4):328-46.
56. Hext PM, Tomenson JA, Thompson P. Titanium dioxide: inhalation toxicology and epidemiology. Ann Occup Hyg. 2005;49(6):461-72.
57. Braakhuis H, Park M, Gosens I, De Jong W, Cassee F. Physicochemical characteristics of nanomaterials that affect pulmonary inflammation. Part Fibre Toxicol. 2014;11(1):18.
58. Simko M, Nosske D, Kreyling WG. Metrics, dose, and dose concept: the need for a proper dose concept in the risk assessment of nanoparticles. Int J Environ Res Public Health. 2014;11(4):4026-48.
59. Duffin R, Tran CL, Clouter A, Brown DM, MacNee W, Stone V, et al. The importance of surface area and specific reactivity in the acute pulmonary inflammatory response to particles. Ann Occup Hyg. 2002;46 suppl 1:242-5.
60. Donaldson K, Borm PJ, Oberdörster G, Pinkerton KE, Stone V, Tran CL. Concordance between in vitro and in vivo dosimetry in the proinflammatory effects of low-toxicity, low-solubility particles: the key role of the proximal alveolar region. Inhal Toxicol. 2008;20(1):53-62.
61. Maynard AD, Kuempel ED. Airborne nanostructured particles and occupational health. J Nanopart Res. 2005;7:587-614.
62. Gebel T, Foth H, Damm G, Freyberger A, Kramer PJ, Lilienblum W, et al. Manufactured nanomaterials: categorization and approaches to hazard assessment. Arch Toxicol. 2014;88(12):2191-211.
63. Elder A, Gelein R, Finkelstein JN, Driscoll KE, Harkema J, Oberdörster G. Effects of subchronically inhaled carbon black in three species. I. Retention kinetics, lung inflammation, and histopathology. Toxicol Sci. 2005;88(2):614-29.
64. Borm PJA, Cakmak G, Jermann E, Weishaupt C, Kempers P, van Schooten FJ, et al. Formation of PAH-DNA adducts after in vivo and vitro exposure of rats and lung cells to different commercial carbon blacks. Toxicol Appl Pharmacol. 2005;205(2):157-67.
65. Oberdörster G. Toxicokinetics and effects of fibrous and nonfibrous particles. Inhal Toxicol. 2002;14(1):29-56.
66. Gallagher J, Sams 2nd R, Inmon J, Gelein R, Elder A, Oberdorster G, et al. ormation of 8-oxo-7,8-dihydro-2-deoxyguanosine in rat lung DNA following subchronic inhalation of carbon black. Toxicol Appl Pharmacol. 2003;190(3):224-31.
67. Tran CL, Buchanan D, Miller BG, Jones AD, Donaldson K. Mathematical modeling to predict the responses to poorly soluble particles in rat lungs. Inhal Toxicol. 2000;12(s3):403-9.
68. Pound P, Ebrahim S, Sandercock P, Bracken MB, Roberts I, on behalf of the Reviewing Animals Trials Systematically (RATS) Group. Where is the evidence that animal research benefits humans? BMJ. 2004;328:514-7.
69. Oberdörster G. Safety assessment for nanotechnology and nanomedicine: nanotoxicology. J Intern Med. 2009;267(1):89-105.
70. ECHA (European Chemicals Agency). Human health and environmental exposure assessment and risk characterisation of nanomaterials. Best practice for REACH registrants. Third GAARN meeting (2013). Available from: http://echa.europa.eu/documents/10162/5399565/best_practices_human_health_environment_nano_3rd_en.pdf. Accessed January 20, 2015.
71. Gebel T. Small difference in carcinogenic potency between GBP nanomaterials and GBP micromaterials. Arch Toxicol. 2012;86(7):995-1007.
72. Gebel T. Response to morfeld (2013): commentary to gebel 2012: a quantitative review should apply meta-analytical methods. Arch Toxicol. 2013;87(5):923-4.
73. Gebel T. Response to Morfeld (2013): second commentary to Gebel 2012-established use of cancer potency indices and biological plausibility. Arch Toxicol. 2013;87(11):2027-9.
74. Morfeld P. Commentary to Gebel 2012: a quantitative review should apply meta-analytical methods. Arch Toxicol. 2013;87(5):921.
75. Morfeld P. Commentary to Gebel 2012: a quantitative review should apply meta-analytical methods-and this applies also to quantitative toxicological reviews. Arch Toxicol. 2013;87(11):2023-5.
76. Tran CL, Buchanan D. Development of a Biomathematical Lung Model to Describe the Exposure-Dose Relationship for Inhaled Dust Among U.K. Coal Miners. Edinburgh, U.K: Institute of Occupational Medicine 2000. Available from: http://www.iom-world.org/pubs/IOM_TM0002.pdf. Accessed November 17, 2014.
77. Sweeney LM, Parker A, Haber LT, Tran CL, Kuempel ED. Application of Markov chain Monte Carlo analysis to biomathematical modeling of respirable dust in US and UK coal miners. Regul Toxicol Pharmacol. 2013;66(1):47-58.
78. Stayner LT, Graber JM. Does exposure to coal dust prevent or cause lung cancer? Occup Environ Med. 2011;68(3):167-8.
79. Morfeld P. Exposure-response association between cumulative exposure to respirable crystalline silica dust and lung cancer. Zbl Arbeitsmed Arbeitsschutz Ergon. 2013;63(4):342-6.
80. Graber JM, Stayner LT, Cohen RA, Conroy LM, Attfield MD. Respiratory disease mortality among US coal miners; results after 37years of follow-up. Occup Environ Med. 2014 71(1):30-9.
81. Attfield MD, Kuempel ED. Mortality among U.S. underground coal miners: a 23-year follow-up. Am J Ind Med. 2008;51(4):231-45.
82. Miller BG, MacCalman L. Cause-specific mortality in British coal workers and exposure to respirable dust and quartz. Occup Environ Med. 2010;67(4):270-6.
83. Taeger D, Hagemeyer O, Merget R, Brüning T, Pallapies D. Letter: is there a lung cancer risk in US coal miners? Occup Environ Med. 2014 71(7):523. March 28, 2014.
84. Morfeld P. Letter: Lung cancer excess risks after coal mine dust exposure? Occup Environ Med.2014 http://oem.bmj.com/content/71/1/30.full/replyoemed_el_3703. Accessed November 3717,2014
85. Graber JM, Cohen RA, Miller BG, Stayner LT. Increased Morbidity and Mortality Among Coal Workers: Lessons Learned from Well-Designed Epidemiological Research Programmes. In: Venables KM, editor. Current Topics in Occupational Epidemiology. United Kingdom: Oxford University Press; 2013. p. 3-16.
86. Morfeld P, Lampert K, Emmerich M, Reischig HL, Klinkner H-G, Bauer H-D, et al. Staubexposition, pneumokoniose und lungenkrebs: eine epidemiologische studie aus dem saarländischen steinkohlenbergbau. Zbl Arbeitsmed Arbeitsschutz Ergon. 2002;52(10):382-97.
87. Morfeld P, Lampert K. Staubexposition, Pneumokonioseentwicklung und Lungenkrebsmortalität: Eine Längschnittstudie an Steinkohlenbergleuten aus dem Saarbergbau. Meckenheim: DCM - Druck Center; 2004.
88. Morfeld P, Emmerich M, Lampert K, Reischig HL, Klinkner HG, Stegmaier C, et al. Mortalität und Krebsmorbidität saarländischer Steinkohlenbergleute, 1980-2002. In: Letzel S, Löffler KI, Seitz C, editors. Deutsche Gesellschaft für Arbeitsmedizin und Umweltmedizin e. V. (DGAUM) - 47. Mainz: Wissenschaftliche Jahrestagung; 2007. p. 387-9.
89. Buchanich JM, Balmert LC, Youk AO, Woolley SM, Talbott EO. General mortality patterns in appalachian coal-mining and non-coal-mining counties. J Occup Environ Med. 2014 56(11):1169-78.
90. Morfeld P. Letter to the editor: Buchanich et al. 2014: The ecologic fallacy may have severely biased the findings. J Occup Environ Med. 2015, 57(2):e13)
91. Boffetta P, Soutar A, Cherrie JW, Granath F, Andersen A, Anttila A, et al. Mortality among workers employed in the titanium dioxide production industry in Europe. Cancer Causes Control. 2004;15(7):697-706.
92. Fryzek JP, Chadda B, Marano D, White K, Schweitzer S, McLaughlin JK, et al. A cohort mortality study among titanium dioxide manufacturing workers in the United States. J Occup Environ Med. 2003;45(4):400-9.
93. Abraham AG, Gange SJ, Rawleigh SB, Glass LR, Springer G, Samet JM. Retrospective mortality study among employees occupationally exposed to toner. J Occup Environ Med. 2010;52(10):1035-41.
94. Kitamura H, Terunuma N, Kurosaki S, Hata K, Masuda M, Kochi T, et al. A cohort study on self-reported respiratory symptoms of toner-handling workers: cross-sectional and longitudinal analysis from 2003 to 2008. Biomed Res Int. 2014;2014:826757.
95. Kitamura H, Terunuma N, Kurosaki S, Hata K, Masuda M, Kochi T, et al. A cohort study using pulmonary function tests and x-ray examination in toner-handling workers: Cross-sectional and longitudinal analyses from 2003 to 2008. Hum Exp Toxicol. 2014; [Epub ahead of print].
96. Kitamura H, Terunuma N, Kurosaki S, Hata K, Masuda M, Kochi T, et al. A cohort study of toner-handling workers on inflammatory, allergic, and oxidative stress markers: Cross-sectional and longitudinal analyses from 2003 to 2008. Hum Exp Toxicol. 2014; [Epub ahead of print].
97. Lee MW, Chen ML, Lung SC, Tsai CJ, Yin XJ, Mao IF. Exposure assessment of PM2.5 and urinary 8-OHdG for diesel exhaust emission inspector. Sci Total Environ. 2010;408(3):505-10.
98. Lettieri Barbato D, Tomei G, Tomei F, Sancini A. Traffic air pollution and oxidatively generated DNA damage: can urinary 8-oxo-7,8-dihydro-2-deoxiguanosine be considered a good biomarker? A meta-analysis. Biomarkers. 2010;15(6):538-45.
99. Baan R, Straif K, Grosse Y, Secretan B, El Ghissassi F, Cogliano V. Carcinogenicity of carbon black, titanium dioxide, and talc. Lancet Oncol. 2006;7(4):295-6.
100. IARC (International Agency for Research on Cancer). Carbon Black, Titanium Dioxide, and Talc. Lyon: IARC; 2010.
101. Kuempel ED, Smith RJ, Dankovic DA, Stayner LT. Rat- and human-based risk estimates of lung cancer from occupational exposure to poorly-soluble particles: a quantitative evaluation. J Phys Conf Ser. 2009;151:1-12.
102. Dell LD, Mundt KA, Luippold RS, Nunes AP, Cohen L, Burch MT, et al. A cohort mortality study of employees in the U.S. carbon black industry. J Occup Environ Med. 2006;48(12):1219-29.
103. Morfeld P, Büchte SF, McCunney RJ, Piekarski C. Lung cancer mortality and carbon black exposure: uncertainties of SMR analyses in a cohort study at a German carbon black production plant. J Occup Environ Med. 2006;48(12):1253-64.
104. Morfeld P, Büchte SF, Wellmann J, McCunney RJ, Piekarski C. Lung cancer mortality and carbon black exposure: cox regression analysis of a cohort from a German carbon black production plant. J Occup Environ Med. 2006;48(12):1230-41.
105. Morfeld P, McCunney RJ. Carbon black and lung cancer: testing a new exposure metric in a German cohort. Am J Ind Med. 2007;50(8):565-7.
106. Morfeld P, McCunney RJ. Carbon black and lung cancer-testing a novel exposure metric by multi-model inference. Am J Ind Med. 2009;52(11):890-9.
107. Morfeld P, McCunney RJ. Bayesian bias adjustments of the lung cancer SMR in a cohort of German carbon black production workers. J Occup Med Toxicol. 2010; Available from: http://www.ncbi.nlm.nih.gov/pubmed/20701747. Accessed 20 January 2015.
108. Sorahan T, Hamilton L, van Tongeren M, Gardiner K, Harrington JM. A cohort mortality study of U.K. carbon black workers, 1951-1996. Am J Ind Med. 2001;39(2):158-70.
109. Sorahan T, Harrington JM. A "lugged" analysis of lung cancer risks in UK carbon black production workers, 1951-2004. Am J Ind Med. 2007;50(8):555-64. May 21.
110. Wellmann J, Weiland SK, Neiteler G, Klein G, Straif K. Cancer mortality in German carbon black workers 1976-1998. Occup Environ Med. 2006;63(8):513-21.
111. Büchte SF, Morfeld P, Wellmann J, Bolm-Audorff U, McCunney RJ, Piekarski C. Lung cancer mortality and carbon black exposure: a nested case-control study at a German carbon black production plant. J Occup Environ Med. 2006;48(12):1242-52.
112. McCunney RJ, Muranko HJ, Long CM, Hamade AK, Valberg PA, Morfeld P. Carbon Black. In: Bingham E, Cohrssen B, editors. Patty's Toxicology, vol. 5. 6th ed. Oxford, UK: John Wiley & Sons; 2012. p. 429-53.
113. Parent ME, Siemiatycki J, Renaud G. Case-control study of exposure to carbon black in the occupational setting and risk of lung cancer. Am J Ind Med. 1996;30(3):285-92.
114. Ramanakumar AV, Parent M-É, Latreille B, Siemiatycki J. Risk of lung cancer following exposure to carbon black, titanium dioxide and talc: results from two case-control studies in Montreal. Int J Cancer. 2008;122(1):183-9.
115. Kayacan O, Beder S, Karnak D. Cellular profile of bronchoalveolar lavage fluid in Turkish miners. Postgrad Med J. 2003;79(935):527-30.
116. Xing J-C, Chen W-H, Han W-H, Guo M-F, Rehn S, Bruch J. Changes of tumor necrosis factor, surfactant protein A, and phospholipids in bronchoalveolar lavage fluid in the development and progression of coal workers' pneumoconiosis. Biomed Environ Sci. 2006;19(2):124-9.
117. Vallyathan V, Goins M, Lapp LN, Pack D, Leonard S, Shi X, et al. Changes in bronchoalveolar lavage indices associated with radiographic classification in coal miners. Am J Respir Crit Care Med. 2000;162(3 Pt 1):958-65.
118. Vanhee D, Gosset P, Wallaert B, Voisin C, Tonnel AB. Mechanisms of fibrosis in coal workers' pneumoconiosis. Increased production of platelet-derived growth factor, insulin-like growth factor type I, and transforming growth factor beta and relationship to disease severity. Am J Respir Crit Care Med. 1994;150(4):1049-55.
119. Vanhee D, Gosset P, Marquette CH, Wallaert B, Lafitte JJ, Gosselin B, et al. Secretion and mRNA expression of TNF alpha and IL-6 in the lungs of pneumoconiosis patients. Am J Respir Crit Care Med. 1995;152(1):298-306.
120. Adachi H, Hayashi H, Sato H, Dempo K, Akino T. Characterization of phospholipids accumulated in pulmonary-surfactant compartments of rats intratracheally exposed to silica. Biochem J. 1989;262(3):781-6.
121. Nehls P, Seiler F, Rehn B, Greferath R, Bruch J. Formation and persistence of 8-oxoguanine in rat lung cells as an important determinant for tumor formation following particle exposure. Environ Health Perspect. 1997;105 Suppl 5:1291-6.
122. Seiler F, Rehn B, Rehn S, Bruch J. Evidence of a no-effect level in silica-induced rat lung mutagenicity but not in fibrogenicity. Arch Toxicol. 2001;74(11):716-9.
123. Seiler F, Rehn B, Rehn S, Hermann M, Bruch J. Quartz exposure of the rat lung leads to a linear dose response in inflammation but not in oxidative DNA damage and mutagenicity. Am J Respir Cell Mol Biol. 2001;24(4):492-8.
124. Donaldson K, Brown GM, Brown DM, Robertson MD, Slight J, Cowie H, et al. Contrasting bronchoalveolar leukocyte responses in rats inhaling coal mine dust, quartz, or titanium dioxide: effects of coal rank, airborne mass concentration, and cessation of exposure. Environ Res. 1990;52(1):62-76.
125. Vanhee D, Gosset P, Boitelle A, Wallaert B, Tonnel AB. Cytokines and cytokine network in silicosis and coal workers' pneumoconiosis. Eur Respir J. 1995;8(5):834-42.
126. Kuempel ED, Attfield MD, Vallyathan V, Lapp NL, Hale JM, Smith RJ, et al. Pulmonary inflammation and crystalline silica in respirable coal mine dust: dose-response. J Biosci. 2003;28(1):61-9.
127. Meyer KC, Raghu G, Baughman RP, Brown KK, Costabel U, du Bois RM, et al. An official American Thoracic Society clinical practice guideline: the clinical utility of bronchoalveolar lavage cellular analysis in interstitial lung disease. Am J Respir Crit Care Med. 2012;185(9):1004-14.
128. Rom WN, Bitterman PB, Rennard SI, Cantin A, Crystal RG. Characterization of the lower respiratory tract inflammation of nonsmoking individuals with interstitial lung disease associated with chronic inhalation of inorganic dusts. Am Rev Respir Dis. 1987;136(6):1429-34.
129. ILSI. The relevance of the rat lung response to particle overload for human risk assessment: A workshop consensus report - Risk Science Institute Workshop. Inhal Toxicol. 2000;12(1-2):1-17.
130. Lehnert BE, Valdez YE, Tietjen GL. Alveolar macrophage-particle relationships during lung clearance. Am J Respir Cell Mol Biol. 1989;1(2):145-54.
131. Ellender M, Hodgson A, Wood KL, Moody JC. Effect of bronchopulmonary lavage on lung retention and clearance of particulate material in hamsters. Environ Health Perspect. 1992;97:209-13.
132. Snipes MB. Long-term retention and clearance of particles inhaled by mammalian species. Crit Rev Toxicol. 1989;20(3):175-211.
133. Kreyling WG. Interspecies comparison of lung clearance of "insoluble" particles. J Aerosol Med. 1990;3(s1):S-93-S-110.
134. Krombach F, Münzing S, Allmeling A-M, Gerlach JT, Behr J, Dörger M. Cell size of alveolar macrophages: an interspecies comparison. Environ Health Perspect. 1997;105 Suppl 5:1261-3.
135. Dörger M, Jesch NK, Rieder G, Hirvonen M-R, Savolainen K, Krombach F, et al. Species differences in NO formation by rat and hamster alveolar macrophages in vitro. Am J Respir Cell Mol Biol. 1997;16(4):413-20.
136. Jesch NK, Dorger M, Enders G, Rieder G, Vogelmeier C, Messmer K, et al. Expression of inducible nitric oxide synthase and formation of nitric oxide by alveolar macrophages: an interspecies comparison. Environ Health Perspect. 1997;105 Suppl 5:1297-300.
137. Levy LS. Review: the 'Particle Overload' phenomenon and human risk assessment. Indoor Environ. 1995;4(5):254-62.
138. Oberdörster G. Pulmonary carcinogenicity of inhaled particles and the maximum tolerated dose. Environ Health Perspect. 1997;105 Suppl 5:1347-55.
139. Greim H, Borm P, Schins R, Donaldson K, Driscoll K, Hartwig A, et al. Toxicity of fibers and particles. Report of the workshop held in Munich, Germany, 26-27 October 2000. Inhal Toxicol. 2001;13(9):737-54.
140. Kolling A, Ernst H, Rittinghausen S, Heinrich U. Relationship of pulmonary toxicity and carcinogenicity of fine and ultrafine granular dusts in a rat bioassay. Inhal Toxicol. 2011;23(9):544-54.
141. Driscoll KE, Deyo LC, Carter JM, Howard BW, Hassenbein DG, Bertram T. Effects of particle exposure and particle-elicited inflammatory cells on mutation in rat alveolar epithelial cells. Carcinogenesis. 1997;18(2):423-30.
142. Jackson JH, Gajewski E, Schraufstatter IU, Hyslop PA, Fuciarelli AF, Cochrane CG, et al. Damage to the bases in DNA induced by stimulated human neutrophils. J Clin Invest. 1989;84(5):1644-9.
143. Weitzman SA, Gordon LI. Inflammation and cancer: role of phagocyte-generated oxidants in carcinogenesis. Blood. 1990;76(4):655-63.
144. Nikula KJ, Avila KJ, Griffith WC, Mauderly JL. Lung tissue responses and sites of particle retention differ between rats and cynomolgus monkeys exposed chronically to diesel exhaust and coal dust. Fundam Appl Toxico. 1997;37(1):37-53.
145. Nikula KJ. Rat lung tumors induced by exposure to selected poorly soluble nonfibrous particles. Inhal Toxicol. 2000;12(1-2):97-119.
146. Green FHY. Pulmonary responses to inhaled poorly soluble particulate in the human. Inhal Toxicol. 2000;12(1-2):59-95.
147. IARC (International Agency for Research on Cancer). Carbon Black: Comparison of Toxicokinetics and Toxicodynamics of Inhaled Poorly Soluble Particles in Animals and Humans. In: World Health Organization, editor. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, vol. 93. Lyon, France: IARC; 2010. p. 166-71.
148. Driscoll KE, Carter JM, Howard BW, Hassenbein DG, Pepelko W, Baggs RB, et al. Pulmonary inflammatory, chemokine, and mutagenic responses in rats after subchronic inhalation of carbon black. Toxicol Appl Pharmacol. 1996;136(2):372-80.
149. Pott F, Roller M. Carcinogenicity study with nineteen granular dusts in rats. Eur J Oncol. 2005;10:249-81.
150. Morfeld P, Albrecht C, Drommer W, Borm PJA. Dose-response and threshold analysis of tumour prevalence after intratracheal instillation of six types of low and high surface area particles in a chronic rat experiment. Inhal Toxicol. 2006;18(4):215-25.
151. OECD. Guidance document on developing and assessing adverse outcome pathways. Paris; 2013. Available from: http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/cote=env/jm/mono(2013)6&doclanguage=en. Accessed November 17, 2014.
152. Vallyathan V, Castranova V, Pack D, Leonard S, Shumaker J, Hubbs AF, et al. Freshly fractured quartz inhalation leads to enhanced lung injury and inflammation. Potential role of free radicals. Am J Respir Crit Care Med. 1995;152(3):1003-9.
153. Yamano Y, Kagawa J, Hanaoka T, Takahashi T, Kasai H, Tsugane S, et al. Oxidative DNA damage induced by silica in vivo. Environ Res. 1995;69(2):102-7.
154. Knaapen AM, Borm PJA, Albrecht C, Schins RPF. Inhaled particles and lung cancer. Part A: Mechanisms. Int J Cancer. 2004;109(6):799-809.
155. Bessho T, Roy R, Yamamoto K, Kasai H, Nishimura S, Tano K, et al. Repair of 8-hydroxyguanine in DNA by mammalian N-methylpurine-DNA glycosylase. Proc Natl Acad Sci U S A. 1993;90(19):8901-4.
156. Carter JM, Corson N, Driscoll KE, Elder A, Finkelstein JN, Harkema JN, et al. A comparative dose-related response of several key pro- and antiinflammatory mediators in the lungs of rats, mice, and hamsters after subchronic inhalation of carbon black. J Occup Environ Med. 2006;48(12):1265-78.
157. Carter JM, Driscoll KE. The role of inflammation, oxidative stress, and proliferation in silica-induced lung disease: a species comparison. J Environ Pathol Toxicol Oncol. 2001;20 Suppl 1:33-43.
158. Seiler F, Rehn B, Rehn S, Bruch J. Significant differences in the cellular and molecular reactions of rat and hamster lung after quartz exposure. Toxicol Lett. 2001;119(1):11-9.
159. Behrens A, Van Deursen JM, Rudolph KL, Schumacher B. Impact of genomic damage and ageing on stem cell function. Nat Cell Biol. 2014;16(3):201-7.
160. OECD. Guidance Document 116 on the conduct and design of chronic toxicity and carcinogenicity studies, supporting test guidlines 451, 452 and 453. 2nd edition. Series on testing and assessment. No. 116. Paris; 2012. Available from: http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV/JM/MONO(2011)47&doclanguage=en. Accessed November 17, 2014.
161. Morfeld P. Letter to the editor: lung dosimetry and risk assessment of nanoparticles. Inhal Toxicol. 2007;19(2):195. author reply 197-198.
162. Smith RG, Musch DC. Occupational exposure to carbon black: a particulate sampling study. Am Ind Hyg Assoc J. 1982;43(12):925-30.
163. Gardiner K, Trethowan WN, Harrington JM, Calvert IA, Glass DC. Occupational exposure to carbon black in its manufacture. Ann Occup Hyg. 1992;36(5):477-96.
164. Gardiner K, Trethowan NW, Harrington JM, Rossiter CE, Calvert IA. Respiratory health effects of carbon black: a survey of European carbon black workers. Br J Ind Med. 1993;50(12):1082-96.
165. Gardiner K. Effects on respiratory morbidity of occupational exposure to carbon black: a review. Arch Environ Health. 1995;50(1):44-60.
166. Gardiner K, van Tongeren M, Harrington M. Respiratory health effects from exposure to carbon black: results of the phase 2 and 3 cross sectional studies in the European carbon black manufacturing industry. Occup Environ Med. 2001;58(8):496-503.
167. Van Tongeren MJ, Kromhout H, Gardiner K. Trends in levels of inhalable dust exposure, exceedance and overexposure in the European carbon black manufacturing industry. Ann Occup Hyg. 2000;44(4):271-80.
168. van Tongeren MJ. Occupational exposure to carbon black dust in the European carbon black manufacturing industry and its respiratory effects. Institute of Occupational Health, Thesis (Doctor of Philosophy); 2000
169. Muranko HJ, Hethmon TA, Smith RG. "Total" and respirable dust exposures in the U.S. carbon black manufacturing industry. AIHAJ. 2001;62(1):57-64.
170. Kerr SM, Muranko HJ, Vincent JH. Personal sampling for inhalable aerosol exposures of carbon black manufacturing industry workers. Appl Occup Environ Hyg. 2002;17(10):681-92.
171. Harber P, Muranko H, Solis S, Torossian A, Merz B. Effect of carbon black exposure on respiratory function and symptoms. J Occup Environ Med. 2003;45(2):144-55.
172. Harber P, Muranko H, Shvartsblat S, Solis S, Torossian A, Oren T. A triangulation approach to historical exposure assessment for the carbon black industry. J Occup Environ Med. 2003;45(2):131-43.
173. ACGIH. Documentation of the threshold limit values and biological exposure indices, 7th ed. Carbon black. In: American Conference of Governmental Industrial Hygienists; 1330 Kemper Meadow Drive, Cincinnati, OH 45240-4148. 2011:8.
174. 10 in bag filling areas of carbon black production. J Occup Environ Hyg. 2004;1:660-71. 01.03.2005.
175. Kuhlbusch TA, Fissan H. Particle characteristics in the reactor and pelletizing areas of carbon black production. J Occup Environ Hyg. 2006;3(10):558-67.
176. Wake D, Mark D, Northage C. Ultrafine aerosols in the workplace. Ann Occup Hyg. 2002;46 suppl 1:235-8.
177. Fryzek JP, Chadda B, Morano D, White K, Schweitzer S, McLaughin JK, et al. A Cohort Mortality Study Among Titanium Dioxide Manufacturing Workers in the United States. 2002.
178. Boffetta P, Soutar A, Weiderpass E, Cherrie J, Granath F, Andersen A, et al. Historical Cohort Study Workers Employed in the Titanium Dioxide Production Industry in Europe. Results of Mortality Follow-up. Stockholm: Department of Medical Epidemiology, Karolinska Institute; 2003.
179. Steenland NK, Bartell SM. Silica exposure: risk assessment for lung cancer, silicosis, and other diseases. Washington DC: U.S. Department of Labor, Occupational Safety and Health Administration; 2004. Available from: http://www.regulations.gov/#documentDetail;D=OSHA-2010-0034-0469. Accessed November 17, 2014.
180. Gold LS, Manley NB, Ames BN. Extrapolation of carcinogenicity between species: qualitative and quantitative factors. Risk Anal. 1992;12(4):579-88.
181. Institute of Occupational Medicine (IOM). The IOM's position on occupational exposure limits for dust. Edinburgh, UK: IOM; 2011. Available from: http://www.iom-world.org/media/93355/ioms_position_on_oels.pdf. Accessed November 17, 2014
182. Wheeler MW, Bailer AJ. Properties of model-averaged BMDLs: a study of model averaging in dichotomous response risk estimation. Risk Anal. 2007;27(3):659-70.
183. Schulte P, Murashov V, Zumwalde R, Kuempel E, Geraci C. Occupational exposure limits for nanomaterials: state of the art. J Nanopart Res. 2010;12(6):1971-87.
184. Morfeld P, Mundt KA, Taeger D, Guldner K, Steinig O, Miller BG. Threshold value estimation for respirable quartz dust exposure and silicosis incidence among workers in the German porcelain industry. J Occup Environ Med. 2013;55(9):1027-34.
185. 2. Inhal Toxicol. 2007;19 Suppl 1:205-12.