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Nickel Compounds NTP REPORT ON CARCINOGENS BACKGROUND DOCUMENT for NICKEL COMPOUNDS FINAL MARCH 1999 Prepared for the December 2-3, 1998, Meeting ofthe Report on Carcinogens Subcommittee ofthe NTP Board of Scientific Counselors Prepared by Integrated Laboratory Systems Post Office Box 13501 Research Triangle Park, North Carolina 27709 NIEHS Contract No. NOl-ES-25346 NTP Report On Carcinogens 1998 Background Document For Nickel Compounds TABLE OF CONTENTS NTP Report on Carcinogens Listing for Nickel Compounds .................................................................................................................... 1 Listing Criteria from the Report on Carcinogens, Eighth Edition 3 1.0 IDENTIFICATION AND CHEMICAL-PHYSICAL PROPERTIES OF NICKEL COMPOUNDS......•.......................................•............... 4 Table 1-1 Chemical and Physical Properties of Nickel and Nickel Compounds.............................................................................. 5 2.0 HUMAN EXPOSURE ......•............•...........................•....•...••.•...••••.......14 2.1 Use ...••.•.......................•.................................•.•.•..•...••.....•.••.••....14 2.2 Production.............................................•......•.............................14 2.1.1 Product Classification and Processes ..............•............14 Table 2-1 Uses of Nickel and Nickel Compounds..•..•.........•..15 2.1.2 Production Volumes ..............................•..............••....16 2.3 Nickel Refining ......................................................•.......•...•..•.....17 2.3.1 Refining Processes •................•.••..........•..........•....•.•.....17 2.3.2 Types of Ores...........................•..•..........•..............•.....17 2.3.3 Refining Operations in the United States.• ...........•.•.•...18 Table 2-2 U.S. & Foreign Mining, Milling, Smelting, and Refining Operations ...................•........................19 2.4 Exposure...................................................................•.................20 2.4.1 Environmental Exposure.............................................20 2.4.2 Occupational Exposure .............•.......•...•..•..................20 Table 2-3 Summary of Current Nickel Exposures in Nickel-Producing and -Using lndustries...•..•..•..••..••...•22 Table 2-4 Groupings for NIOSH Survey Data......................23 Table 2-5 Potential Occupational Exposure Estimates for Nickel Compounds from NIOSH Surveys..............26 Table 2-6 Potential Nickel Sulfate Occupational Exposure Estimates from NIOSH Surveys ....•....•...........•............35 Table 2-7 Potential Nickel Oxide Occupational Exposure Estimates from NIOSH Surveys................................. .40 2.5 Regulations and Criteria ..............................•............................•.44 iii NTP Report On Carcinogens 1998 Background Document For Nickel Compounds ~.0 ~~ ~1rl[J][)I~~ ••••••••••••..••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••:;:; 3.1 Review of Nickel Compound Epidemiology (IARC, 1990, and ICNCM, 1990) ...................•.•..•...•......•..•••.•.•..•.•..•.••.•.•....•.55 3.2 Studies Post-IARC (1990).......- ..........•.........••.•................•..•...••....56 3.2.1 Metallic Nickel ...............•...........•..•...••...•.•..•.••••..•..••.•.•...56 3.2.2 Nickel Carbonyl ..........•..•........•..........•...•..•.•.••.••..•......•...56 3.2.3 Oxidic Nickel ..................................................................51 3.2.4 Soluble Nickel ..•............................•..•...•......................•...57 3.0 Other Occupational Exposure Studies ...................•...................•.58 Table 3-1 Studies of Human Exposure to Nickel Published Post-IARC (1990) ........................•.•..••.••......•...•.......•..•......•.....60 4.0 EXPERIMENTAL CARCINOGENESIS ..•...•........................................67 4.1 Studies Reviewed in IARC (1990) ..........•.....................................67 4.2 Animal Carcinogenicity Studies Post-IARC (1990) •......................67 4.2.1 NTP (1996) Studies of Nickel Oxide, Nickel Sulfate Hexahydrate, and Nickel Subsulfide .....•...•..•.•.........•...••.67 4.2.2 Nickel Subsulfide ....•.........•...........•......••......•........•....•...•68 4.2.3 Nickel Acetate .........•.............................•.•....•..•..........•....68 Table 4-1 Post-IARC (1990) Experimental Carcinogenicity Studies of Nickel Compounds ......................•............•....•..•...............•..70 5.0 GENOTOXICITY ..............................................•..........................•......76 5.1 Review of Animal Genotoxicity Studies (IARC, 1990) ........•....•....76 5.1.1 Metallic Nickel .......................•..•.••......•....•..•.............•.....76 5.1.2 Nickel Oxides and Hydroxides ........••..........••.•........•........76 5.1.3 Crystalline Nickel Sulfide, Crystalline Nickel Subsulfide, and Amorphous Nickel Sulfide ...........................•...........76 5.1.4 Nickel Chloride, Nickel Sulfate, Nickel Acetate, and Nickel Nitrate.................................................................76 5.1.5 Nickel Carbonate, Nickelocene, Nickel Potassium Cyanide, and Nickel Subselenide.........•..................•........ 77 5.2 Review of Human Genotoxicity Studies (IARC, 1990) ••.••.••..........77 5.2.1 Metallic Nickel ..................•...........•......••....................•...•77 5.2.2 Nickel Oxides and Hydroxides .........................................77 5.2.3 Nickel Sulfides ......................................•.•.................•.....78 5.2.4 Nickel Sulfate and Nickel Chloride ..................................78 5.2.5 Mixed Exposures .......................................•.....................78 5.3 Animal Genotoxicity Studies Published Post-IARC (1990) ....•......79 5.4 Human Genotoxicity Studies Published Post-IARC (1990) •......••••79 IV NTP Report On Carcinogens 1998 Background Document For Nickel Compounds 5.5 Cogenotoxicity ........................................................•......•....•.••...•79 Table 5-1 Genotoxicity of Nickel Studies Published Post-IARC (15)9())•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• ~() Table 5-2 Cogenotoxicity of Nickel Studies Published Post-IARC (1~90)......................................................................................~~ 6.0 OTHER RELEVANT DATA ......................................•...•..•••..•.•...........84 6.1 Absorption, Distribution, and Excretion in Experimental Ani111~Is ................................................•.......................••....~" 6.2 Toxicokinetics of Nickel in Humans....................•....•.•...........•.....84 6.3 Biokinetics and Evidence of Exposure in Nickel Workers .............85 7.0 MECHANISMS OF CARCINOGENESIS•..•..........•...•....•...••.•••••.••...•...85 ~.0 RE~~RENC~~ .....................................................•...••.....................•...~~ APPENDIX A - Excerpts from the IARC Monograph on the Evaluation of the Carcinogenic Risks to Humans, Volume 49 (Chromium, Nickel and Welding), Nickel and Nickel Compounds, pp. 257-445, 616-638, 1990............•..........•.••......•............................ A-1 APPENDIX B - Report on Carcinogens (RoC), 9th Edition Review Summary ......................•..................••.•.........•......•..•.......•..B-1 v NTP Report On Carcinogens 1998 Background Document For Nickel Compounds NTP Report on Carcinogens Listing for Nickel Compounds Carcinogenicity Nickel compounds are known to be human carcinogens based on findings ofincreased risk of cancers in exposed workers and evidence of malignant tumor formation by multiple routes of exposure at various sites in multiple species ofexperimental animals. The combined results of epidemiological studies, carcinogenesis studies in rodents, and mechanistic data support the concept that nickel compounds act by the generation of nickel ions at critical sites in target cells of carcinogenesis and allow consideration and evaluation ofthese compounds as a single group. In 1990, an IARC evaluation ofnickel and nickel compounds concluded that "nickel compounds are carcinogenic to humans" (IARC, 1990) based on sufficient evidence for the carcinogenicity of human exposure to nickel compounds as would be found in the nickel refining industry, and very strong evidence of carcinogenicity of a variety ofnickel compounds in rodents. In several cohort studies ofworkers exposed to various nickel compounds, the risk for death from lung cancer and nasal cancer are elevated (IARC, 1990). Although the precise nickel compound responsible for the carcinogenic effects in humans is not always clear, studies indicate that nickel sulfate and the combinations ofnickel sulfides and oxides encountered in the nickel refining industries are carcinogenic to humans. IARC (1990) made the overall evaluation of nickel compounds as a group based on indications from animal and mechanistic studies that the generation ofionic nickel in the target site is the event responsible for carcinogenic transformation. Additional study has shown that exposure to soluble nickel compounds alone or in combination with other forms ofnickel in nickel refinery workers results in a significant excess risk of lung and nasal cancers and that smoking and nickel had a multiplicative effect (Andersen et al., 1996). Nickel exposure in welders is associated with carcinoma ofthe trachea, bronchus, and lung in some cases (Simonato, 1991), although these results are complicated by co-exposure to carcinogenic
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