Publication
Regulatory practices on the genotoxicity testing of nanomaterials and outlook for the future
| dc.contributor.author | Andreoli, Cristina | |
| dc.contributor.author | Dusinska, Maria | |
| dc.contributor.author | Bossa, Cecilia | |
| dc.contributor.author | Battistelli, Chiara Laura | |
| dc.contributor.author | Silva, Maria João | |
| dc.contributor.author | Louro, Henriqueta | |
| dc.date.accessioned | 2025-11-10T15:09:20Z | |
| dc.date.available | 2025-11-10T15:09:20Z | |
| dc.date.issued | 2025-06-06 | |
| dc.description.abstract | Highlights: - Genotoxicity testing of chemicals requires multiple tests to cover key endpoints; - NMs have distinct properties that require adaptations of conventional testing; - Approaches for genotoxicity testing of the NMs reviewed show challenges; - The level of harmonization between different frameworks is debated; - New approach methodologies are underlined to support NMs'regulation. | eng |
| dc.description.abstract | The toxicity of nanomaterials(NMs) is closely tied to their physicochemical properties, such as size, shape, surface chemistry, stability in biological medium, and state of agglomeration as well to their uptake by cells. Key deficiencies in standardized testing approaches have been identified and tackled in recent years. Within the landscape of new approach methods (NAMs), the aim of this work is to review existing approaches for genotoxicity testing of the NMs under different regulatory domains, with a perspective on the development of NAMs that can solve longstanding difficulties in NMs’ risk assessment. It critically examines international and European Union guidelines, highlighting the need for harmonization and the potential of NAMs to drive next-generation risk assessment. However, further collaboration, research and validation are essential to gain wider acceptance and applicability. The contribution of innovative technological approaches based on big data, artificial intelligence and machine learning, may pave powerful comparisons among different sectors and grouping strategies that will furtherance innovation in the nanotoxicology research. The future outlook for the genotoxicity testing of NMs will depend on increased cooperation between regulatory agencies, researchers, and industry stakeholders. Key steps toward overcoming current obstacles include establishing clearer pathways for data sharing, standardizing testing protocols, and fostering greater international collaboration. | eng |
| dc.description.sponsorship | This work was supported by the author’s institutions and by the Partnership for the Assessment of Risks from Chemicals (PARC) that has received funding from the European Union’s Horizon Europe Research and Innovation Programme under Grant Agreement No. 101057014. This work is part of the PARC WP6.3 Case Study 11 entitled “Analysis and evaluation of genotoxicity and carcinogenicity assessment across legislations, with a special focus on (Q)SAR based approaches”, within the PARC. The authors thank the PARC WP6 Leaders and WP6 partners for fruitful discussions. | |
| dc.identifier.citation | Regul Toxicol Pharmacol. 2025 Nov:162:105881. doi: 10.1016/j.yrtph.2025.105881. Epub 2025 Jun 6 | |
| dc.identifier.doi | 10.1016/j.yrtph.2025.105881 | |
| dc.identifier.issn | 0273-2300 | |
| dc.identifier.pmid | 40482696 | |
| dc.identifier.uri | http://hdl.handle.net/10400.18/10579 | |
| dc.language.iso | eng | |
| dc.peerreviewed | yes | |
| dc.publisher | Elsevier | |
| dc.relation | European Partnership for the Assessment of Risks from Chemicals (PARC) | |
| dc.relation.hasversion | https://www.sciencedirect.com/science/article/pii/S0273230025001114?via%3Dihub | |
| dc.relation.ispartof | Regulatory Toxicology and Pharmacology | |
| dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | |
| dc.subject | Nanomaterials | |
| dc.subject | Regulation | |
| dc.subject | Environmental Genotoxicity | |
| dc.subject | Genotoxicidade Ambiental | |
| dc.subject | NAM | |
| dc.subject | Carcinogenicity | |
| dc.subject | Genotoxicidade Ambiental | |
| dc.title | Regulatory practices on the genotoxicity testing of nanomaterials and outlook for the future | eng |
| dc.type | journal article | |
| dspace.entity.type | Publication | |
| oaire.awardTitle | European Partnership for the Assessment of Risks from Chemicals (PARC) | |
| oaire.awardURI | http://hdl.handle.net/10400.18/10383 | |
| oaire.citation.startPage | 105881 | |
| oaire.citation.title | Regulatory Toxicology and Pharmacology | |
| oaire.citation.volume | 162 | |
| oaire.fundingStream | Horizon Europe Guarantee | |
| oaire.version | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |
| person.familyName | Louro | |
| person.givenName | Henriqueta | |
| person.identifier | 157627 | |
| person.identifier.ciencia-id | 721D-2BB1-7DB1 | |
| person.identifier.orcid | 0000-0001-9744-7332 | |
| person.identifier.scopus-author-id | 6507971479 | |
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| relation.isAuthorOfPublication.latestForDiscovery | 2361a951-8b9a-4b90-92d6-f6384003a242 | |
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