KOPS - The Institutional Repository of the University of Konstanz

Internationalization of read-across as a validated new approach method (NAM) for regulatory toxicology

Aufgrund von Vorbereitungen auf eine neue Version von KOPS, können derzeit keine Publikationen eingereicht werden. (Due to preparations for a new version of KOPS, no publications can be submitted currently.)

Internationalization of read-across as a validated new approach method (NAM) for regulatory toxicology

Cite This

Files in this item

Checksum: MD5:61b050f2f245418053ae7b8dcc02ae6a

ROVIDA, Costanza, Tara BARTON-MACLAREN, Emilio BENFENATI, Francesca CALONI, Charu CHANDRASEKERA, Daniel R. DIETRICH, Jaffar KISITU, Marcel LEIST, Giorgia PALLOCCA, Thomas HARTUNG, 2020. Internationalization of read-across as a validated new approach method (NAM) for regulatory toxicology. In: Alternatives to Animal Experimentation : ALTEX. Springer Spektrum. 37(4), pp. 579-606. ISSN 1868-596X. eISSN 1868-8551. Available under: doi: 10.14573/altex.1912181

@article{Rovida2020Inter-49443, title={Internationalization of read-across as a validated new approach method (NAM) for regulatory toxicology}, year={2020}, doi={10.14573/altex.1912181}, number={4}, volume={37}, issn={1868-596X}, journal={Alternatives to Animal Experimentation : ALTEX}, pages={579--606}, author={Rovida, Costanza and Barton-Maclaren, Tara and Benfenati, Emilio and Caloni, Francesca and Chandrasekera, Charu and Dietrich, Daniel R. and Kisitu, Jaffar and Leist, Marcel and Pallocca, Giorgia and Hartung, Thomas} }

<rdf:RDF xmlns:dcterms="http://purl.org/dc/terms/" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:rdf="http://www.w3.org/1999/02/22-rdf-syntax-ns#" xmlns:bibo="http://purl.org/ontology/bibo/" xmlns:dspace="http://digital-repositories.org/ontologies/dspace/0.1.0#" xmlns:foaf="http://xmlns.com/foaf/0.1/" xmlns:void="http://rdfs.org/ns/void#" xmlns:xsd="http://www.w3.org/2001/XMLSchema#" > <rdf:Description rdf:about="https://kops.uni-konstanz.de/rdf/resource/123456789/49443"> <dcterms:hasPart rdf:resource="https://kops.uni-konstanz.de/bitstream/123456789/49443/1/Rovida_2-1np5yt7qtdnu88.pdf"/> <dcterms:issued>2020</dcterms:issued> <dc:creator>Chandrasekera, Charu</dc:creator> <dc:creator>Kisitu, Jaffar</dc:creator> <dc:date rdf:datatype="http://www.w3.org/2001/XMLSchema#dateTime">2020-05-08T07:24:20Z</dc:date> <dc:contributor>Kisitu, Jaffar</dc:contributor> <dc:creator>Barton-Maclaren, Tara</dc:creator> <dc:contributor>Chandrasekera, Charu</dc:contributor> <dc:creator>Dietrich, Daniel R.</dc:creator> <dc:contributor>Caloni, Francesca</dc:contributor> <dc:creator>Pallocca, Giorgia</dc:creator> <dcterms:abstract xml:lang="eng">Read-across (RAx) translates available information from well-characterized chemicals to the substance for which there is a toxicological data gap. The OECD is working on case studies to probe general applicability of RAx, and several regulations (e.g. EU-REACH) already allow this procedure to be used to waive new in vivo tests. The decision to prepare a review on the state of the art of RAx as a tool for risk assessment for regulatory purposes was taken during a workshop with international experts in Ranco, Italy in July 2018. Three major issues were identified that need optimisation to allow a higher regulatory acceptance rate of the RAx procedure: (i) the definition of similarity of source and target, (ii) the translation of biological/toxicological activity of source to target, in the RAx procedure, and (iii) how to deal with issues of ADME that may differ between source and target. The use of new approach methodologies (NAM) was discussed as one of the most important innovations to improve the acceptability of RAx. At present, NAM data may be used to confirm chemical and toxicological similarity. In the future, the use of NAM may be broadened to fully characterize the hazard and toxicokinetic properties of RAx compounds. Concerning available guidance, documents on Good Read-Across Practice (GRAP) and on best practices to perform and evaluate the RAx process were identified. Here, in particular the RAx guidance, being worked out by the European Commission’s H2020 project EU-ToxRisk, together with many external partners with regulatory experience, is given.</dcterms:abstract> <dc:creator>Benfenati, Emilio</dc:creator> <dspace:hasBitstream rdf:resource="https://kops.uni-konstanz.de/bitstream/123456789/49443/1/Rovida_2-1np5yt7qtdnu88.pdf"/> <dc:contributor>Pallocca, Giorgia</dc:contributor> <dcterms:title>Internationalization of read-across as a validated new approach method (NAM) for regulatory toxicology</dcterms:title> <foaf:homepage rdf:resource="http://localhost:8080/jspui"/> <dc:contributor>Hartung, Thomas</dc:contributor> <dcterms:available rdf:datatype="http://www.w3.org/2001/XMLSchema#dateTime">2020-05-08T07:24:20Z</dcterms:available> <dc:contributor>Leist, Marcel</dc:contributor> <dc:creator>Leist, Marcel</dc:creator> <dc:creator>Hartung, Thomas</dc:creator> <dc:language>eng</dc:language> <dspace:isPartOfCollection rdf:resource="https://kops.uni-konstanz.de/rdf/resource/123456789/28"/> <void:sparqlEndpoint rdf:resource="http://localhost/fuseki/dspace/sparql"/> <dcterms:rights rdf:resource="http://creativecommons.org/licenses/by/4.0/"/> <dc:contributor>Rovida, Costanza</dc:contributor> <dcterms:isPartOf rdf:resource="https://kops.uni-konstanz.de/rdf/resource/123456789/28"/> <dc:rights>Attribution 4.0 International</dc:rights> <dc:contributor>Barton-Maclaren, Tara</dc:contributor> <dc:contributor>Benfenati, Emilio</dc:contributor> <dc:creator>Caloni, Francesca</dc:creator> <dc:creator>Rovida, Costanza</dc:creator> <dc:contributor>Dietrich, Daniel R.</dc:contributor> <bibo:uri rdf:resource="https://kops.uni-konstanz.de/handle/123456789/49443"/> </rdf:Description> </rdf:RDF>

Downloads since May 8, 2020 (Information about access statistics)

Rovida_2-1np5yt7qtdnu88.pdf 385

This item appears in the following Collection(s)

Attribution 4.0 International Except where otherwise noted, this item's license is described as Attribution 4.0 International

Search KOPS


My Account