title: The use of non-tumor data in cancer risk assessment: reflections on butadiene, vinyl chloride, and benzene.
abstract: The estimation and characterization of a cancer risk is grounded in the observation of tumors in humans and/or experimental animals. Increasingly, however, other kinds of data (non-tumor data) are finding application in cancer risk assessment. Metabolism and kinetics, adduct formation, genetic damage, mode of action, and biomarkers of exposure, susceptibility, and effects are examples. While these and other parameters have been studied for many important chemicals over the past 30-40 years, their use in risk assessments is more recent, and new insights and opportunities are continuing to unfold. To provide some perspective on this field, the ILSI Risk Science Institute asked a select working group to characterize the pertinent non-tumor data available for 1,3-butadiene, benzene, and vinyl chloride and to comment on the utility of these data in characterizing cancer risks. This paper presents the findings of that working group and concludes with 15 simple principles for the use of non-tumor data in cancer risk assessment.
authors.affiliation: University of Vermont, Burlington, VT 05401, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Albertini
authors.forename: Harvey
authors.initials: H
authors.lastname: Clewell
authors.forename: Matthew W
authors.initials: MW
authors.lastname: Himmelstein
authors.forename: Eric
authors.initials: E
authors.lastname: Morinello
authors.forename: Stephen
authors.initials: S
authors.lastname: Olin
authors.forename: Julian
authors.initials: J
authors.lastname: Preston
authors.forename: Louis
authors.initials: L
authors.lastname: Scarano
authors.forename: Martyn T
authors.initials: MT
authors.lastname: Smith
authors.forename: James
authors.initials: J
authors.lastname: Swenberg
authors.forename: Raymond
authors.initials: R
authors.lastname: Tice
authors.forename: Curtis
authors.initials: C
authors.lastname: Travis
mesh_terms: D000818:Animals; D001554:Benzene / Q000378:metabolism / Q000493:pharmacokinetics / Q000633:toxicity*; D015415:Biomarkers / Q000032:analysis; D002070:Butadienes / Q000378:metabolism / Q000493:pharmacokinetics / Q000633:toxicity*; D015197:Carcinogenicity Tests; D002273:Carcinogens / Q000378:metabolism / Q000493:pharmacokinetics / Q000633:toxicity*; D018736:DNA Adducts / Q000378:metabolism; D006801:Humans; D009152:Mutagenicity Tests; D009369:Neoplasms / Q000139:chemically induced; D018570:Risk Assessment / Q000379:methods; D014752:Vinyl Chloride / Q000378:metabolism / Q000493:pharmacokinetics / Q000633:toxicity*
chemical_list: D015415:Biomarkers; D002070:Butadienes; D002273:Carcinogens; D018736:DNA Adducts; D001554:Benzene; D014752:Vinyl Chloride