The use of mechanistic data and the handling of scientific uncertainty in carcinogen risk assessments - The trichloroethylene example
2002 (English)In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 35, no 1, 80-94 p.Article in journal (Refereed) Published
The purpose of this paper is to explore how risk assessors actually use mechanistic data in carcinogen risk assessment and to discuss how the handling of scientific uncertainty may affect the outcome of the risk assessment. The analysis is performed by comparing 29 trichloroethylene risk assessment documents in general and 2 of these, namely the ECETOC (1994, Trichloroethylene: Assessment of Human Carcinogenic Hazard, Technical Report No. 60) and the OECD/EU (1996, Initial Assessment Report for the 4th SIAM (Screening Information Data Set Initial Assessment Meeting), May 1996: Trichloroethylene, sponsor country, United Kingdom [Draft]), in more detail. It is concluded that in this example the ECETOC required less evidence for considering a carcinogenic mechanism irrelevant to humans than did the OECD/EU risk assessors. There are examples of when two risk assessors have selected different primary data for their argumentation and also examples of how one and the same primary publication was interpreted differently. Biased data selection and evaluation of primary data that correlate to the risk assessor's overall conclusions have also been identified. The general comparison of all 29 TCE risk assessment documents indicates that the assessment of scientific uncertainty in the mechanistic data affects the overall conclusions.
Place, publisher, year, edition, pages
2002. Vol. 35, no 1, 80-94 p.
dry cleaning workers, dichloroacetic acid, species-differences, chloral hydrate, mouse lung, clara cell, exposure, mice, metabolism, trichloroacetate
IdentifiersURN: urn:nbn:se:kth:diva-21347DOI: 10.1006/rtph.2001.1508ISI: 000174046500008OAI: oai:DiVA.org:kth-21347DiVA: diva2:340045
QC 201005252010-08-102010-08-10Bibliographically approved