Scrutinizing three trichloroethylene carcinogenicity classifications in the European Union - Implications for the risk assessment process

International Journal of Toxicology

Volumn 21, Issue 6, 2002, Pages 441-450

  Rudén, Christina ^a,b  

^a ROYAL INSTITUTE OF TECHNOLOGY   (Sweden)

^b KAROLINSKA INSTITUTE   (Sweden)

Author keywords

Carcinogenicity; Classification Criteria; Downstream Regulations; Precautionary Principle; Regulatory Toxicology; Risk Management

Indexed keywords

CARCINOGEN; TRICHLOROETHYLENE;

ACUTE TOXICITY; CARCINOGENICITY; CHEMICAL CARCINOGENESIS; CLASSIFICATION; DATA BASE; ECOTOXICITY; EUROPEAN UNION; MEDICAL SOCIETY; MUTAGENICITY; REPRODUCTIVE TOXICITY; REVIEW; RISK ASSESSMENT; RISK MANAGEMENT;

ANIMALS; CARCINOGENS; DATABASES, FACTUAL; EUROPEAN UNION; HUMANS; RISK ASSESSMENT; TRICHLOROETHYLENE;

EID: 0036951609     PISSN: 10915818     EISSN: None     Source Type: Journal    
DOI: 10.1080/10915810290169864     Document Type: Review

References (53)

1. Anttila, A., E. Pukkala, M. Sallmén, S. Hernberg, and K. Hemminki. 1995. Cancer incidence among Finnish workers exposed to halogenated hydrocarbons. J. Occup. Environ. Med. 37:797-806.
2. Axelson, O. 1986. Epidemiologigacl studies of workers with exposure to tri-and tetrachlorethylenes. Toxicol. Lett. 31(suppl):17.
3. Axelson, O., K. Andersson, A. Seldén, and C. Hogstedt. 1984. Cancer morbidity and exposure to trichloroethylene. Arbete och Hälsa 29:126 (abstract).
4. Axelson, O., A. Seldén, K. Andersson, and C. Hogstedt. 1994. Updated and expanded Swedish cohort study on trichloroethylene and cancer risk. J. Occup. Med. 36:556-562.
5. Birner, G., S. Vamvakas, W. Dekant, and D. Henschler. 1993. The nephrotoxic and genotoxic N-acetyl-S-dichlorovinyl-L-cystein is a urinary metabolite after occupational 1,1,2-trichloroethene exposure in humans. Environ. Health Perspect. 99:281-284.
6. Blair, A., P. Decoufle, and D. Grauman. 1979. Causes of death among laundry and dry cleaning workers. Am. J. Public Health 69:508-511.
7. Blair, A., P. Hartge, P. A. Stewart, M. McAdams, and J. Lubin. 1998. Mortality and cancer incidence of aircraft maintenance workers exposed to trichloroethylene and other organic solvents and chemicals: Extended follow up. Occup. Environ. Med. 55:161-171.
8. Boice, J. D., Jr., D. E. Marano, J. P. Fryzek, C. J. Sadler, and J. K. McLaughlin. 1999. Mortality among aircraft manufacturing workers. Occup. Environ. Med. 56:581-597.
9. Bonse, G., and D. Henschler. 1976. Chemical reactivity, biotransformation, and toxicity of polychlorinated aliphatic compounds. CRC Crit. Rev. Toxicol 4(4):395-409.
10. Bonse, G., Th. Urban, D. Reichert, and D. Henschler. 1975. Chemical reactivity, metabolic oxirane formation and biological reactivity of chlorinated ethyelens in the isolated perfused rat liver preparation. Biochem. Pharmacol. 24:1829-1834.
11. Brauch, H., G. Wairich, M. A. Hornauer, S. Störkel, T. Wöhl, and T. Brüning. 1999. Trichloroethylene exposure and specific somatic mutations in patients with renal cell carcinoma. J. Natl. Cancer Inst. 91:854-861.
12. Brüning, T., and H. M. Bolt. 2000. Renal toxicity and carcinogenicity of trichloroethylene: Key results, mechanisms and controversies. Crit. Rev. Toxicol. 30:253-285.
13. Commission Directive 76/907/EEC of 14 July 1976 adapting to technical progress [1st ATP] the Council Directive of 27 June 1967 concerning the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal L 360, 30/12/1976, pp. 0001-0424.
14. Commission Directive 88/490/EEC of 22 July 1988 on the tenth adaptation to technical progress [10th ATP] of Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal L 259, 19/09/1988, pp. 0001-0024.
15. Commission Directive 83/467/EEC. Official Journal L257/1, 1983.
16. Commission Directive 93/21/EEC. Official Journal L 110, 1993.
17. Commission Directive 2001/59/EC. Official Journal L225/1, 2001.
18. Council Directive 67/548/EEC. Official Journal L196/1, 1967. Council Directive 76/769/EEC. Official Journal L262, 1976.
19. Dekant, W., and D. Henschler. 1999. Organ-specific carcinogenicity of haloalkenes mediated by glutathione conjugation. J. Cancer Res. Clin. Oncol. 125:174-181.
20. Elcombe, C. R., M. S. Rose, and I. S. Pratt. 1985. Biochemical, histological, and ultrastructural changes in rat and mouse liver following the administration of trichloroethylene: Possible relevance to species difference in hepatocarcinogenicity. Toxicol. Appl. Pharmacol. 79:365-376.
21. European Commission. 2000a. Draft summary record from the Meeting of the Commission Working Group on the Classification and Labelling of Dangerous Substances. ECBI/51/00, 21.09.2000.
22. European Commission. 2000b. Summary Record of Conclusions - Commission Group of Specialised Experts in the fields of Carcinogenicity, Mutagenicity and Reprotoxicity. ECB1/24/00-Rev. 2, 04.05.2000.
23. European Commission. 2000c. First report on the harmonisation of risk assessment procedures, part 1, 26-27. October 2000.
24. European Commission. 2001. White paper - Strategy for a future chemicals policy COM(2001)88 final. Brussels, 27.2.2001.
25. Fukuda, K., K. Takemoto, and H. Tsuruta. 1983. Inhalation carcinogenicity of Trichloroethylene in mice and rats. Ind. Health 21:243-254.
26. Green, L. C., and T. L. Lash. 1999. Letter to the editors: Re: "Renal cell cancer correlated with occupational exposure to trichloroethylene." J. Cancer Res. Clin. Oncol. 125:430-432.
27. Hardell, L., M. Eriksson, P. Lenner, and E. Lundgren. 1981. Malignant lymphoma and exposure to chemicals, especially organic solvents, chlorophenols and phenoxy acids: A case-control study. Br. J. Cancer 43:169-176.
28. Henschler, D., G. Bonse, and H. Greim. 1976. Carcinogenic potential of chlorinated ethylenes: Tentative molecular rules. In Environmental pollution and carcinogenic risks, vol. 52,171-176. Lyon, France. IARC Scientific Publications.
29. Henschler, D., H. Elsässer, W. Romen, and E. Eder. 1984. Carcinogenicity study of trichloroethylene, with and without epoxide stabilizers, in mice. J. Cancer Res. Clin. Oncol. 107:149-156.
30. Henschler, D., W. Romen, H. M. Elsässer, D. Reichert, E. Eder, and Z. Radwan. 1980. Carcinogenicity study of trichloroethylene by longterm inhalation in three animal species. Arch. Toxicol. 43:237-248.
31. Henschler, D., S. Vamvakas, M. Lammert, W. Dekant, B. Kraus, B. Thomas, and K. Ulm. 1995. Increased incidence of renal cell tumors in a cohort of cardboard workers exposed to trichloroethylene. Arch. Toxicol. 69:291-299.
32. International Agency for Research on Cancer (IARC). 1987. Monographs on the evaluation of carcinogenic risks to humans. Update of volumes 1 to 42. Suppl. 7. Lyon, France: IARC.
33. IARC. 1995. Monographs on the evaluation of carcinogenic risks to humans. Dry cleaning, some chlorinated solvents and other industrial chemicals, vol. 63. Lyon, France: IARC.
34. Katz, R. M., and D. Jowett. 1981, Female laundry and dry cleaning workers in Wisconsin: A mortality analysis. Am. J. Public Health 71:305-307.
35. Maltoni, C., G. Lefemine, and G. Cotti. 1986. Experimental research on trichloroethylene carcinogenesis. In Archives of research in industrial carcinogenesis, vol. V., eds. C. Maltoni and M. A. Mehlman, 54-138. Princeton, NJ: Princeton Scientific Publishing.
36. Morgan, R. W., M. A. Kelsh, K. Zhao, and S. Heringer. 1998. Mortality of aerospace workers exposed to trichloroethylene. Epidemiology 9:424-431.
37. National Cancer Institute (NCI) 1976. Carcinogenesis bioassay of trichloroethylene. DHEW publication no. (NIH) 76-802.
38. National Toxicology Program (NTP). 1988. Toxicology and Carcinogenesis studies of trichloroethylene (CAS No. 79-01-6) in four strains of rats (ACI, August, Marshall, Osborne-Mendel) (gavage studies). Technical report 273, PB88-218896 Research Triangle Park, NC: NTP.
39. NTP. 1990. Carcinogenesis studies of trichloroethylene (without epichlorohydrin) (CAS No. 79-01-6) in F344N Rats and B6C3F1 mice (gavage studies). Technical report 243, PB 91-111815. Research Triangle Park, NC: NTP.
40. OECD/EU. 1996. Initial Assessment Report for the 4th SIAM, May 1996. Trichloroethylene (Draft).
41. Page, N. P., and J. L. Arthur. 1978. Special occupational hazard review of trichloroethylene. Publication no. 78-130. Rockville, MD: NIOSH, U.S. Department of Health Education and Welfare.
42. Persson, B., A. M. Dahlander, M. Fredriksson, H. N. Brage, C. G. Ohlson, and O. Axelson. 1989. Malignant lymphomas and occupational exposure. Br. J. Ind. Med. 46:516-520.
43. Rudén, C. 2001a. The use and evaluation of primary data in 29 trichloroethylene carcinogen risk assessments. Regul. Toxicol. Pharmacol. 34:3-16.
44. Rudén, C. 2001b. Interpretations of primary carcinogenicity data in 29 trichloroethylene risk assessments. Toxicology 169:209-225.
45. Rudén, C. 2002. The use of mechanistic data and the handling of scientific uncertainty in carcinogen risk assessments - The trichloroethylene example. Regul. Toxicol. Pharmacol. 34:80-94.
46. Sandin, P., M. Peterson, S. O. Hansson, C. Rudén, and A. Juthe. 2002. Five charges against the precautionary principle. J. Risk Res. 5(4):287-299.
47. Schraml, R., M. Zhaou, J. Richter, Th. Brüning, M. Pommer, G. Sauter, M. J. Mihatsch, and H. Moch. 1999. Analysis of renal tumors in trichloroethylene-exposed workers by comparative genomic hybridization and DNA sequencing analysis. Verhandl. Deut. Gesell. Pathol. 83:218-224.
48. Spirtas, R., P. Stewart, S. Lee, D. E. Marano, C. D. Forbes, D. J. Grauman, H. M. Pettigrew, A. Blair, R. N. Hoover, and J. L. Cohen. 1991. Retrospective cohort mortality study of workers at an aircraft maintenance facility I. Epidemiological results. Br. J. Ind. Med. 48:515-530.
49. Tola, S., R. Vilhunen, E. Jaarvinen, and M.-L. Korkala. 1980. A cohort study on workers exposed to trichloroethylene. J. Occup. Med. 22:737-740.
50. Uehleke, H., S. Poplawski, G. Bonse, and D. Henschler. 1976. Spectral evidence for 2,2,3-trichloro-oxirane formation during microsomal trichloroethylene oxidation (abstract). Arch. Pharmacol. 293:R64, 253.
51. Vamvakas, S., T. Brüning, H. M. Bolt, D. Henschler, and K. Ulm. 2000. Letter to the editors: Renal cell cancer correlated with occupational exposure to trichloroethene. J. Cancer Res. Clin, Oncol. 126:178-180.
52. Vamvakas, S., T. Brüning, B. Thomasson, H. Lammert, A. Baumüller, H. M. Bolt, W. Dekant, G. Birner, D. Henschler, and K. Ulm. 1998. Renal cell cancer correlated with occupational exposure to trichloroethylene. J. Cancer Res. Clin. Oncol. 124:374-382.
53. Wartenberg, D., D. Reyner, and C. Siegel Scott. 2000. Trichloroethylene and cancer: Epidemiologic evidence. Environ. Health Perspect. 108(suppl 2):161-176.