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Analysis and evaluation of genotoxicity and carcinogenicity assessment in EU legislation to improve regulatory implementation of NAMs: A focus on in silico approaches

2025-06Documento de conferência Acesso restrito
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datacite.subject.fosCiências Médicas::Ciências da Saúde
datacite.subject.sdg03:Saúde de Qualidade
dc.contributor.authorBossa, Cecília
dc.contributor.authorRaitano, Giuseppa
dc.contributor.authorBenfenati, Emilio
dc.contributor.authorAlivernini, Silvia
dc.contributor.authorAndreoli, Cristina
dc.contributor.authorAquilina, G.
dc.contributor.authorAttias, L.
dc.contributor.authorDusinska, Maria
dc.contributor.authorEl Yamani, N.
dc.contributor.authorLouro, Henriqueta
dc.contributor.authorMarcon, Francesca
dc.contributor.authorRundèn-Pran, E.
dc.contributor.authorRusso, Maria Teresa
dc.contributor.authorSilva, Maria João
dc.contributor.authorBattistelli, Chiara Laura
dc.date.accessioned2026-02-13T11:29:16Z
dc.date.available2026-02-13T11:29:16Z
dc.date.issued2025-06
dc.description.abstractGenotoxicity and carcinogenicity are key endpoints for the risk assessment of all types of substances. Research on alternatives to animal testing for these endpoints has been active for decades, leading to the development of short-term in vitro tests that are integrated into current testing strategies. Nevertheless, high relevance is still devoted to data from in vivo studies. In parallel, progress in the comprehension of mechanisms underpinning genotoxicity and genotoxic carcinogenicity processes, together with the analysis of the great wealth of experimental data produced, allowed the discovery of structural determinants utilized in quantitative and qualitative structure-activity relationships and enabling in silico predictions of these endpoints. Presented here is a case study part of the collective effort carried out within the European Partnership for the Assessment of Risks from Chemicals (PARC) to address the challenges associated with innovation in chemical risk assessment, including the phasing out of animal testing through the introduction of New Approach Methodologies (NAMs) [1,2]. The case study aims to analyze current practices of the regulatory evaluation of genotoxicity and carcinogenicity hazard in several EU frameworks, in order to highlight needs and challenges in the actual or potential use of NAMs as well as short-and long- term goals towards the overcoming of animal testing. Among other NAMs, we are focusing on the role of in silico approaches highlighting strategies to increase the regulatory application and acceptance of QSAR based approaches. To this aim, the OECD QSAR Assessment Framework [3,4] has been identified as a suitable tool for evaluating the models and their predictions and will be applied to selected case studies. Moreover, a list of human relevant carcinogens has been developed as reference chemicals to evaluate and possibly refine in silico methodologies supporting a human-centric paradigm shift in toxicology.eng
dc.description.sponsorshipThis work was carried out in the framework of the European Partnership for the Assessment of Risks from Chemicals (PARC) and has received funding from the European Union’s Horizon Europe research and innovation program under Grant Agreement No 101057014.
dc.identifier.urihttp://hdl.handle.net/10400.18/10927
dc.language.isoeng
dc.peerreviewedyes
dc.relationEuropean Partnership for the Assessment of Risks from Chemicals (PARC)
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectGenotoxicit y
dc.subjectCarcinogenicity
dc.subjectSilico
dc.subjectRisk Assessment
dc.subjectGenotoxicidade Ambiental
dc.titleAnalysis and evaluation of genotoxicity and carcinogenicity assessment in EU legislation to improve regulatory implementation of NAMs: A focus on in silico approacheseng
dc.typeconference object
dspace.entity.typePublication
oaire.awardTitleEuropean Partnership for the Assessment of Risks from Chemicals (PARC)
oaire.awardURIhttp://hdl.handle.net/10400.18/10383
oaire.citation.conferenceDate2025-06-03
oaire.citation.conferencePlaceMilan, Italy
oaire.citation.title21st International Workshop on Quantitative Structure-Activity Relationships in Environmental and Health Sciences (QSAR), 3-6 June 2025
oaire.fundingStreamHorizon Europe Guarantee
oaire.versionhttp://purl.org/coar/version/c_b1a7d7d4d402bcce
relation.isProjectOfPublicationa7df9a6a-838e-406c-94c7-1baa7daba05c
relation.isProjectOfPublication.latestForDiscoverya7df9a6a-838e-406c-94c7-1baa7daba05c

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