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Roc Background Document: Tetrafluoroethylene; March 1999

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Roc Background Document: Tetrafluoroethylene; March 1999 NTP REPORT ON CARCINOGENS BACKGROUND DOCUMENT for TETRAFLUOROETHYLENE FINAL MARCH 1999 Prepared for the October 30-31, 1997, Meeting ofthe Report on Carcinogens Subcommittee ofthe NTP Board ofScientific Counselors Prepared by Integrated Laboratory Systems Post Office Box 13501 Research Triangle Park, North Carolina 27709 NIEHS Contract No. N01-ES-25346 NTP Report on Carcinogens 1997 Background Document for Tetratluoroethylene TABLE OF CONTENTS NTP Report on Carcinogens Listing for Tetrafluoroethylene ........................... 1 Listing Criteria from the Report on Carcinogens, Eighth Edition •.••••••••••••••••• 2 1.0 CHEMICAL PROPERTIES•••.••.••..•.••.••...••.••.•.••.•.••••.••.•.••••••.•••••.••••••••••••••.•.•• 3 1.1 Chemical Identification .••.•.•••••.••.••.••.•.••.••••.•..••••.•.•.•.••••••••.••••••••••••.•.•.•.• 3 1.2 Physical-Chemical Properties ••••••.•.•••••••.•.•.••.•.••.•.••••••••••.•.•.••••••.•.••..•.•. 3 2.0 HUMAN EXPOSURE •.••.••••.••.••.•.•••••.••...••.••.•.••.•..•.•.••••..•••.•••...•.•.•.•.•.•••.•••.•..•• 4 2.1 Production •.........•.......•.•.........•.•.......•........••..•....••.......•...............•........... 4 2.2 Use •••••.•.••••••.•.•••••••••.••••••..•.•••••.••.•••••••.•.•••.•.••.••••.•.•.••••.•.•.•••...••••••.••••.•.•.•.• 4 2.3 Environmental Exposure ..•..•..•••••••.•••••••.•.••.••••.••••••••••...••......••..•••••.•••..• 4 2.4 Occupational Exposure •••.•..•.•••••.••.••••.••.•.••.•..•.••••.•.•.•.•••..•••.•••••.•••.••••••.• 4 Table 2-1 NIOSH National Occupational Exposure Survey (NOES, 1980-83): By Industry •.•..•....••.•.•....••.•.•....•...•.•...•.•.•....••.•..... 4 2.5 Regulations •.••••••.••.••••.••.•••••.•.••.•••••.••.••••.••.••.•.••.•••.••.•.•.•..•••.•••.•••••.••.•.•...• 5 3.0 HUMAN STUDIES ••••••••••••••••••••••••••••.•••••••••••••••••••••••••••••••••••••••••.•••••••.•••••••••••• 8 4.0 EXPERIMENTAL CARCINOGENICITY ••.••.•••••••••••.••••.••••••••••.•..••.••••••••••• 8 4.1 Mice •.••••••••••••••.••••.•.••.•••••.•.•••••••••••.•••••••.••••.••••.••.••••.•.•.•.••••.•.•••.•.•.•.•••••••.•• 8 4.2 Rats•••••.•••.•••••••••••••••••••.••.••••.••.••.•••••••.••.•..••••.•.••••.••••.•••.••.•.•.•.•.•.•.•••.•.•.•.•.• 9 5.0 GENOTOXICITY•.•.••••.••.•.••.••.•.••••••••.••.••••.••.••••.•.••.•..•.•.•..•.•••.•.•..••.•.•..••••••.•...• 9 5.1 Prokaryotic Systems •.•••••••.••.•••••••.••.••••..•.••.•.••.•.••.•••.•.••.•.•.•.•.•.•••.•.•..••.• 10 5.2 In Vitro Mammalian Systems •.••••••••.•••••••••.•••••••••.•.••••••.•.•.•.•.•.•••.•.•••••• 10 5.3 In Vivo Mammalian Systems •.••.•.••.••.•••••••••.•••••••.•.•.•.••.•.•.•...•.•.•..•••••... 10 Table 5-1 Summary ofTetrafluoroethylene Genotoxicity Studies •...•.•• 11 6.0 OTHER RELEVANT DATA•..••••.•.•..•••••..•..•••.•..•.•..•.••.•.•.••.•.•.••..•••.•.•.•.•••••.•. 12 6.1 Absorption, Distribution, and Excretion•.•.••...••.•.••..••.•....••.•.....•.•...•.• 12 6.2 Metaholism •••••••.•.••.•••••••.••••..•.•••••.••.••.••••.••.•.••••.••.•.•.••...•.•.•...•.•.•.•.•••.•••. 12 6.3 Pharmacokinetics•••••••••••••••••••••••••••••••.••••••••••••••••••••••••••••••.•••••••.•••••.•.••• 13 6.4 Structure-Activity Relationships •••••.•••••••••.•••••••••.••••••.•••••.•••••••.•••••.•••. 13 6.4.1 Cysteine S-Conjugates ••••••••••••••••••••.••••••.••••••••.•••.•.•.•.•.•••.••••••• 13 6.4.2 Tetrachloroethylene •.•••••••.•.•••.•.••••.•.••.••••••.•.••••••••.•••••••.••••••.••• 13 6.5 Tumor Mutations•••••••••••••••.••••••••••••••••••••••••••••••••••••••••••••••.••••••••••••••••••• 14 iii NTP Report on Carcinogens 1997 Background Document for Tetrafluoroetbylene 7.0 MECHANISMS OF CARCINOGENESIS .................................................. 14 Figure 7-1 Proposed Mechanism for the Metabolic Activation of TFE in the Male Rat ......................................................................... 15 8.0 REFERENCES ................................................................................................ 15 APPENDIX A - Excerpts from the IARC Monograph on the Evaluation of the Carcinogenic Risk of Chemicals to Humans, Volume 19 (Some Monomers, Plastics and Synthetic Elastomers, and Acrolein), Tetrafluoroethylene and Polytetrafluoroethylene, pp. 285-301, 1979 ...................................................................................... A-1 APPENDIX B - Excerpts from the NTP Technical Report, Toxicology and Carcinogenesis Studies of Tetrafluoroethylene in F344/N Rats and B6C3F1 Mice (Inhalation Studies), April1997, pp. 3-32, 69-78 ........................................................................................... B-1 APPENDIX C- Description of Online Searches for Tetrafluoroethylene •••• C-1 APPENDIX D - Report on Carcinogens (RoC), 9th Edition Review Summary ...................................................................................... D-1 lV NTP Report on Carcinogens 1997 Background Document for Tetrafluoroethylene NTP Report on Carcinogens Listing for Tetratluoroethylene Carcinogenicity Tetrafluoroethylene (TFE) is reasonably anticipated to be a human carcinogen based on sufficient evidence ofmalignant tumor formation at multiple sites in multiple species of experimental animals (NTP, 1997). When administered by inhalation to F344 rats, TFE induced renal tubule neoplasms, hepatocellular neoplasms, liver hemangiosarcoma, and mononuclear cell leukemia. When administered by inhalation to B6C3F 1 mice, TFE induced liver hemangiomas and hemangiosarcomas, hepatocellular neoplasms, and histiocytic sarcomas. There are no adequate data available to evaluate the carcinogenicity ofTFE in humans. Other Information Relating to Carcinogenesis or Possible Mechanisms of Carcinogenesis In prokaryotic systems, TFE was negative for the induction of gene mutations in Salmonella typhimurium with and without S9 activation (Haskell Laboratory, 1986a; cited by HSDB, 1997). In mammalian systems in vitro, TFE was also negative for the induction of gene mutations in Chinese hamster ovary cells (Haskell Laboratory, 1986b; cited by HSDB, 1997). No increases in the frequency ofmicronucleated erythrocytes were observed in peripheral blood samples obtained from TFE-exposed mice (NTP, 1997). The frequency ofH ras codon 61 mutations observed in TFE-induced hepatocellular neoplasms (15%) was significantly less than the corresponding frequency (56-59%) in spontaneous liver neoplasms ofB6C3F1 mice, suggesting that TFE induces liver neoplasms via a ras-independent pathway (NTP, 1997). The kidney-specific toxicity and carcinogenicity ofTFE is most likely related to the selective uptake and subsequent processing ofTFE-glutathione conjugates by renal ~-lyase (Miller and Surh, 1994; Anders et al., 1988). In rats, a TFE cysteine conjugate is bioactivated in the kidney to a difluorothionacetyl fluoride, the putative reactive metabolite for TFE-induced nephrotoxicity (NTP, 1997). No data are available that would suggest that the mechanisms thought to account for tumor induction by TFE in experimental animals would not also operate in humans. 1 NTP Report on Carcinogens 1997 Background Document for Tetrafluoroethylene Listing Criteria from the Report on Carcinogens, Eighth Edition Known To Be A Human Carcinogen: There is sufficient evidence ofcarcinogenicity from studies in humans which indicates a causal relationship between exposure to the agent, substance or mixture and human cancer. Reasonably Anticipated To Be A Human Carcinogen: There is limited evidence ofcarcinogenicity from studies in humans, which indicates that causal interpretation is credible, but that alternative explanations, such as chance, bias or confounding factors, could not adequately be excluded, or There is sufficient evidence ofcarcinogenicity from studies in experimental animals which indicates there is an increased incidence ofmalignant and/or a combination of malignant and benign tumors: (1) in multiple species or at multiple tissue sites, or (2) by multiple routes ofexposure, or (3) to an unusual degree with regard to incidence, site or type oftumor, or age at onset; or There is less than sufficient evidence of carcinogenicity in humans or laboratory animals, however; the agent, substance or mixture belongs to a well~defined, structurally related class ofsubstances whose members are listed in a previous Report on Carcinogens as either a known to be human carcinogen or reasonably anticipated to be human carcinogen, or there is convincing relevant information that the agent acts through mechanisms indicating it would likely cause cancer in humans. Conclusions regarding carcinogenicity in humans or experimental animals are based on scientific judgment, with consideration given to all relevant information. Relevant information includes, but is not limited to dose response, route ofexposure, chemical structure, metabolism, pharmacokinetics, sensitive sub populations, genetic effects, or other data relating to mechanism of action or factors that may be unique to a given substance. For example, there may be substances for which there is evidence ofcarcinogenicity in laboratory animals but there are compelling data indicating that the agent acts through mechanisms which do not operate in humans and would therefore not reasonably be anticipated to cause cancer in humans. 2 NTP Report on Carcinogens 1997 Background Document for Tetrafluoroetbylene 1.0 CHEMICAL PROPERTIES Tetrafluoroethylene [116-14-3] F F 't-! 1-\ 1.1 Chemical Identification Tetrafluoroethylene (C2F4, mol. wt. = 100.02) is also called: Ethene, tetrafluoro- (9CI) Ethylene, tetrafluoro- (SCI) Ethylene, tetrafluoro- (inhibited) Fluoroplast 4 Perfluoroethene Perfluoroethylene Tetrafluoroethene Tetrafluoroethylene,
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