Title: Genetic toxicology in silico protocol
Authors: HASSELGREN CATRINAHLBERG ERNSTAKAHORI YUMIAMBERG ALEXANDERANGER LENNART TATIENZAR FRANCKAUERBACH SCOTTBEILKE LISA D.BELLION PHILLIPBENIGNI ROMUALDOBERCU JOELBOOTH EWAN DBOWER DAVEBRIGO ALESSANDROCAMMERER ZORYANACRONIN MARKCROOKS IANCROSS KEVIN P.CUSTER LAURADOBO KRISTADOKTOROVA TATYANAFAULKNER DAVIDFORD KEVIN A.FORTIN MARI CFRERICKS MARKUSGAD-MCDONALD SAMANTHA EGELLATLY NICHOLAGERETS HELGAGERVAIS VÉRONIQUEGLOWIENKE SUSANNEVAN GOMPEL JACKYHARVEY JAMESHILLEGASS JEDDHONMA MASAMITSUHSIEH JUI-HUAHSU CHIA-WENBARTON-MACLAREN TARAJOHNSON CANDICEJOLLY ROBERTJONES DAVIDKEMPER RAYKENYON MICHELLEKRUHLAK NAOMIKULKARNI SUNIL AKUEMMERER KLAUSLEAVITT PENNYMASTEN SCOTTMILLER SCOTTMOUDGAL CHANDRIKAMUSTER WOLFGANGPAULINO ALEXANDRELO PIPARO ELENAPOWLEY MARKQUIGLEY DONALD P.REDDY M VIJAYARAJRICHARZ ANDREASCHILTER BENOÎTSNYDER RONALD D.STAVITSKAYA LIDIYASTIDL REINHARDSZABO DAVID TTEASDALE ANDREWTICE RAYMOND R.TREJO-MARTIN ALEJANDRAVUORINEN ANNAWALL BRIAN AWATTS PETEWHITE ANGELAWICHARD JOERGWITT KRISTINEWOOLLEY ADAMWOOLLEY DAVIDZWICKL CRAIGMYATT GLENN
Citation: REGULATORY TOXICOLOGY AND PHARMACOLOGY vol. 107 no. 104403 p. 1-21
Publisher: ACADEMIC PRESS INC ELSEVIER SCIENCE
Publication Year: 2019
JRC N°: JRC113688
ISSN: 0273-2300 (online)
URI: https://www.sciencedirect.com/science/article/pii/S0273230019301655
https://publications.jrc.ec.europa.eu/repository/handle/JRC113688
DOI: 10.1016/j.yrtph.2019.104403
Type: Articles in periodicals and books
Abstract: In silico toxicology (IST) approaches to rapidly assess chemical hazard, and usage of such methods is increasing in all applications but especially for regulatory submissions, such as for assessing chemicals under REACH as well as the ICH M7 guideline for drug impurities. There are a number of obstacles to performing an IST assessment, including uncertainty in how such an assessment and associated expert review should be performed or what is fit for purpose, as well as a lack of confidence that the results will be accepted by colleagues, collaborators and regulatory authorities. To address this, a project to develop a series of IST protocols for different hazard endpoints has been initiated and this paper describes the genetic toxicity in silico (GIST) protocol. The protocol outlines a hazard assessment framework including key effects/mechanisms and their relationships to endpoints such as gene mutation and clastogenicity. IST models and data are reviewed that support the assessment of these effects/mechanisms along with defined approaches for combining the information and evaluating the confidence in the assessment. This protocol has been developed through a consortium of toxicologists, computational scientists, and regulatory scientists across several industries to support the implementation and acceptance of in silico approaches.
JRC Directorate:Health, Consumers and Reference Materials

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