Science and transscience in carcinogen risk assessment - The European Union regulatory process for trichloroethylene

Journal of Toxicology and Environmental Health - Part B: Critical Reviews

Volumn 6, Issue 3, 2003, Pages 257-278

  Rudén, Christina ^a,b  

^a ROYAL INSTITUTE OF TECHNOLOGY   (Sweden)

^b KAROLINSKA INSTITUTE   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

CARCINOGEN; TRICHLOROETHYLENE;

ARTICLE; CANCER RISK; CARCINOGENICITY; EUROPEAN UNION; GERMANY; HEALTH HAZARD; MUTAGENICITY; RISK ASSESSMENT; SWEDEN; UNITED KINGDOM;

EID: 0037408384     PISSN: 10937404     EISSN: None     Source Type: Journal    
DOI: 10.1080/10937400306467     Document Type: Article

References (33)

1. Anttila, A., Pukkala E., Sallmén, M., Hernberg, S., and Hemminki, K. 1995. Cancer incidence among Finnish workers exposed to halogenated hydrocarbons. J. Occup. Environ. Med. 37:797-806.
2. Axelson, O., Seldén, A., Andersson, K., and Hogstedt, C. 1994. Updated and expanded Swedish cohort study on trichloroethylene and cancer risk. J. Occup. Med. 36:556-562.
3. Blair, A., Decoutle, P., and Grauman, D. 1979. Causes of death among laundry and dry cleaning workers. Am. J. Publ. Health. 69:508-511.
4. Brauch, H., Wairich, G., Hornauer, M. A., Störkel, S., Wöhl, T., and Brüning, T. 1999. Trichloroethylene exposure and specific somatic mutations in patients with renal cell carcinoma. JNCI 91:854-861.
5. Council Directive (EEC) 67/548 of 27 June 1967 approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances. 1967. Official J. 196.
6. Council Regulation (EEC) 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances. 1993. Official J. 84.
7. Commission Directive (EC) 2001/59 of 6 August 2001 adapting to technical progress for the 28th time Council directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances. 2001. Official J. L225/1.
8. Commission Regulation (EC) No 1179/94 of 25 May 1994 concerning the first list of priority substances as foreseen under Council Regulation (EEC) No 793/93. 1994. Official J. L131.
9. Douglas, G. R., Gingerich, J. D., Soper, L. M., Potvin, M., and Bjarnason, S. 1999. Evidence for the lack of base-change and small-deletion mutation induction by trichloroethylene in lacZ transgenic mice. Environ. Mol. Mutagen. 34:190-194.
10. Fahrig, R., Madle, S., and Baumann, H. 1995. Genetic toxicology of trichloroethylene (TCE). Mutat. Res. 340:1-36.
11. Henschler, D., Elsässer, H., Romen, W., and Eder, E. 1984. Carcinogenicity study of trichloroethylene, with and without epoxide stabilizers, in mice. J. Cancer Res. Clin. Oncol. 107:149-156.
12. Henschler, D., Vamvakas, S., Lammert, M., Dekant, W., Kraus, B., Thomas, B., and Ulm, K. 1995. Increased incidence of renal cell tumors in a cohort of cardboard workers exposed to trichloroethylene. Arch. Toxicol. 69:291-299.
13. International Agency For Research on Cancer. 1995a. Dry cleaning, Some chlorinated solvents and other industrial chemicals. Monogr. Eval. Carcinogen. Risks Hum. 63.
14. International Agency For Research on Cancer. 1995b. Peroxisome proliferation and its role in carcinogenesis, views and expert opinions of an IARC working group, Lyon 7-9 December 1994. IARC Tech. Rep. No. 24. Lyon: IARC Press.
15. Kautiainen, A., Vogel, J. S., and Turteltaub, K. W. 1997. Dose-dependent binding of trichloroethylene to hepatic DNA and protein at low doses in mice. Chem. Biol. Interact. 106:109-121.
16. A. D., Bryant, M. F., Doerr, C. L, Erexson, G. L., Evansky, P. A., Kwanyuen, P., and McGee, J. K. 1994. Inhalation studies of the genotoxicity of trichloroethylene to rodents. Mutat. Res. 322:87-96.
17. Maltoni, C., Lefemine, G., and Cotti, G. 1986. Experimental research on trichloroethylene carcinogenesis. In Archives of research in industrial carcinogenesis, vol. V, pp. 54-138, eds. C. Maltoni and M. A. Mehlman, Princeton, NJ: Institute of Oncology, Princeton Scientific.
18. National Cancer Institute. 1976. Carcinogenesis bioassay of trichloroethylene. DHEW publication no. (NIH) 76-802.
19. National Toxicology Program. 1988. Toxicology and carcinogenesis studies of trichloroethylene (CAS No. 79-01-6) in four strains of rats (ACI, August, Marshall, Osborne-Mendel) (gavage studies). Tech. Rep. 273, PB88-218896. Research Triangle Park, NC.
20. National Toxicology Program. 1990. Carcinogenesis studies of trichloroethylene (without epichlorohydrin) (CAS No. 79-01-6) in F344/N rats and B6C3F1 mice (garage studies). Tech. Rep. 243, PB 91-111815. Research Triangle Park, NC.
21. OECD/EU. 1996. Initial assessment report for the first SIAM. May 1996 Trichloroethylene (draft). United Kingdom: Health and Safety Executive.
22. Reddy, J. K., and Rao, M. S. 1992. Peroxisome proliferation and hepatocarcinogenesis. In Mechanisms of carcinogenesis in risk identification, pp. 225-235, eds. H. Vainio, P. N., Magee, D. B. McGregor, and A. J. McMichel. IARC Sci. Pub. No. 116. Lyon: IARC.
23. Robbiano, L., Mereto, E., Migliazzi Morando, A., Pastore, P., and Brambilla, G. 1998. Increased frequency of micronucleated kidney cells in rats exposed to halogenated anaesthetics. Mutat. Res. 23:1-6.
24. Rudén, C. 2001a. The use and evaluation of primary data in 29 trichloroethylene carcinogen risk assessments. Regul. Toxicol. Pharmacol. 34:3-16.
25. Rudén, C. 2001b. Interpretations of primary carcinogenicity data in 29 trichloroethylene risk assessments. Toxicology 169:209-225.
26. Rudén, C. 2002. The use of mechanistic data and the handling of scientific uncertainty in carcinogen risk assessments - The trichloroethylene example. Regul. Toxicol. Pharmacol. 35:80-94.
27. Schiestl, R. H., Aubrecht, J., Khogali, F., and Cads, N. 1997. Carcinogens induce reversion of the mouse pink-eyed unstable mutation. Proc. Natl. Acad. Sci. USA 94:4576-4581.
28. Shelby, M. D., Erexson, G. L., Hook, G. J., and Tice, R. R. 1993. Evaluation of a three-exposure mouse bone marrow micronucleus protocol: Results with 49 chemicals. Environ. Mol. Mutagen. 21:160-179.
29. Spirtas, R., Stewart, P., Lee, S., Marano, D. E., Forbes, C. D., Grauman, D. J., Pettigrew, H. M., Blair, A., Hoover, R. N., and Cohen, J. L. 1991. Retrospective cohort mortality study of workers at an aircraft maintenance facility I. Epidemiological results. Br. J. Ind. Med. 48:515-530.
30. Sujatha, T. V., and Hegde, M. J. 1998. C-mitotic effects of trichloroethylene (TCE) on bone marrow cells of mice. Mutat. Res. 16:151-158.
31. United Kingdom. 1996. Initial assessment report for the 4th SIAM (Screening information data set initial Assessment Meeting), May 1996. Trichloroethylene (Draft). Organisation for Economic Co-operation and Development (OECD). United Kingdom: Health and Safety Executive.
32. Vamvakas, S., Brüning, T., Thomasson, B., Lammert, H., Baumüller, A., Bolt, H. M., Dekant, W., Birner, G., Henschler, D., and Ulm, K. 1998. Renal cell cancer correlated with occupational exposure to trichloroethylene. J. Cancer Res. Clin. Oncol. 124:374-382
33. Weinberg, A. M. 1972. Science and transscience. Minerva 10:208-222.