IWGT report on quantitative approaches to genotoxicity risk assessment II. Use of point-of-departure (PoD) metrics in defining acceptable exposure limits and assessing human risk

Mutation Research - Genetic Toxicology and Environmental Mutagenesis

Volumn 783, Issue , 2015, Pages 66-78

  MacGregor, James T ^a   Frötschl, Roland ^b   White, Paul A ^c   Crump, Kenny S ^d   Eastmond, David A ^e   Fukushima, Shoji ^f   Guérard, Melanie ^g   Hayashi, Makoto ^h   Soeteman Hernández, Lya G ⁱ   Johnson, George E ^j   Kasamatsu, Toshio ^k   Levy, Dan D ^l   Morita, Takeshi ^m   Müller, Lutz ^g   Schoeny, Rita ⁿ   Schuler, Maik J ^o   Thybaud, Véronique ^p  

^a Toxicology Consulting Services   (United States)

^b Federal Institute for Drugs and Medical Devices Bundesinstitut für Arzneimittel und Medizinprodukte   (Germany)

^c HEALTH CANADA   (Canada)

^d University of California ^*  (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f Japan Bioassay Research Center   (Japan)

^g F HOFFMANN LA ROCHE LTD   (Switzerland)

^h Genotoxicology Laboratory Safety Assessment Unit   (Japan)

ⁱ NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^j SWANSEA UNIVERSITY   (United Kingdom)

^k KAO CORPORATION   (Japan)

^l CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^m NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

ⁿ U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

^o PFIZER INC   (United States)

^p SANOFI   (France)

more..

Author keywords

Benchmark dose; Breakpoint dose; Extrapolation; Genotoxic risk assessment; Low dose risk; Point of departure

Indexed keywords

ARTICLE; ASSAY; BACTERIAL MUTAGENICITY ASSAY; CARCINOGENESIS; GENOTOXICITY; HUMAN; IN VITRO STUDY; MALIGNANT NEOPLASTIC DISEASE; MAMMAL CELL; METABOLIC ACTIVATION; NONHUMAN; PRIORITY JOURNAL; RISK ASSESSMENT; SPECIES IDENTIFICATION; TARGET ORGAN; ANTIBODY SPECIFICITY; CHEMICALLY INDUCED; CHROMOSOME ABERRATION; DNA DAMAGE; DOSE RESPONSE; DRUG EFFECTS; GENETICS; METABOLISM; MUTAGEN TESTING; NEOPLASM; PATHOLOGY; PROCEDURES; STANDARDS;

ANIMALIA;

MUTAGENIC AGENT;

CHROMOSOME ABERRATIONS; DNA DAMAGE; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; MUTAGENICITY TESTS; MUTAGENS; NEOPLASMS; ORGAN SPECIFICITY; RISK ASSESSMENT;

EID: 84928809223     PISSN: 13835718     EISSN: 18793592     Source Type: Journal    
DOI: 10.1016/j.mrgentox.2014.10.008     Document Type: Article

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