A classification framework and practical guidance for establishing a mode of action for chemical carcinogens

Regulatory Toxicology and Pharmacology : RTP
B E Butterworth

Abstract

The recently released U.S. Environmental Protection Agency (U.S. EPA) Supplemental Guidance for Assessing Risk from Early Life Exposure to Carcinogens (SGAC) provides guidance to account for potential increased early life susceptibility to carcinogens that are acting via a mutagenic mode of action. While determination of the mode of carcinogenic action is central to the SGAC procedures and other regulatory risk assessments, little guidance is given as to the approaches, criteria, and nature of the evidence required to define a mutagenic mode of action. The purpose of this paper is to provide a framework along with practical guidance for the process of assigning a mode of action. Strengths, weaknesses, reliability, and choice of a test battery are discussed for select bacterial, cell culture, whole animal and human cell assays. Common confounding factors of induced pathology, cytolethality, and regenerative cell proliferation in rodent cancer bioassays are discussed along with approaches to account for these effects in assigning a mode of action and in risk assessments. Specific examples are given to illustrate the complexity in generating a data set sufficient to move from the default regulatory position of assuming a genotoxic...Continue Reading

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Citations

Apr 28, 2012·Toxicological Sciences : an Official Journal of the Society of Toxicology·Nicola J StaggJames E Klaunig
May 9, 2012·Mutation Research. Reviews in Mutation Research·David A Eastmond
Dec 30, 2015·Regulatory Toxicology and Pharmacology : RTP·Ann E BradleyJudi L Durda
Jun 10, 2009·Regulatory Toxicology and Pharmacology : RTP·Takeshi MoritaToshio Sofuni
Sep 9, 2008·Regulatory Toxicology and Pharmacology : RTP·Michael DoursonMelissa Kohrman
Mar 28, 2008·Regulatory Toxicology and Pharmacology : RTP·B L YanoD L Eisenbrandt
Aug 11, 2007·Regulatory Toxicology and Pharmacology : RTP·Byron E ButterworthSean M Hays
Sep 1, 2007·Regulatory Toxicology and Pharmacology : RTP·Byron E Butterworth, John R Chapman
Oct 18, 2016·Arhiv za higijenu rada i toksikologiju·Alja PlošnikMarija Sollner Dolenc
Jan 30, 2015·Brazilian Journal of Biology = Revista Brasleira De Biologia·R FactoriS M Thomaz
Feb 2, 2008·Environmental and Molecular Mutagenesis·Nancy McCarrollRita Schoeny
May 8, 2017·EFSA Journal·UNKNOWN EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)Alicja Mortensen

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