000121236 001__ 121236
000121236 005__ 20240319081024.0
000121236 0247_ $$2doi$$a10.1186/s12989-022-00499-2
000121236 0248_ $$2sideral$$a131879
000121236 037__ $$aART-2022-131879
000121236 041__ $$aeng
000121236 100__ $$aSiivola, Kirsi M.
000121236 245__ $$aA systematic quality evaluation and review of nanomaterial genotoxicity studies: a regulatory perspective
000121236 260__ $$c2022
000121236 5060_ $$aAccess copy available to the general public$$fUnrestricted
000121236 5203_ $$aThe number of publications in the field of nanogenotoxicology and the amount of genotoxicity data on nanomaterials (NMs) in several databases generated by European Union (EU) funded projects have increased during the last decade. In parallel, large research efforts have contributed to both our understanding of key physico-chemical (PC) parameters regarding NM characterization as well as the limitations of toxicological assays originally designed for soluble chemicals. Hence, it is becoming increasingly clear that not all of these data are reliable or relevant from the regulatory perspective. The aim of this systematic review is to investigate the extent of studies on genotoxicity of NMs that can be considered reliable and relevant by current standards and bring focus to what is needed for a study to be useful from the regulatory point of view. Due to the vast number of studies available, we chose to limit our search to two large groups, which have raised substantial interest in recent years: nanofibers (including nanotubes) and metal-containing nanoparticles. Focusing on peer-reviewed publications, we evaluated the completeness of PC characterization of the tested NMs, documentation of the model system, study design, and results according to the quality assessment approach developed in the EU FP-7 GUIDEnano project. Further, building on recently published recommendations for best practices in nanogenotoxicology research, we created a set of criteria that address assay-specific reliability and relevance for risk assessment purposes. Articles were then reviewed, the qualifying publications discussed, and the most common shortcomings in NM genotoxicity studies highlighted. Moreover, several EU projects under the FP7 and H2020 framework set the aim to collectively feed the information they produced into the eNanoMapper database. As a result, and over the years, the eNanoMapper database has been extended with data of various quality depending on the existing knowledge at the time of entry. These activities are highly relevant since negative results are often not published. Here, we have reviewed the NanoInformaTIX instance under the eNanoMapper database, which hosts data from nine EU initiatives. We evaluated the data quality and the feasibility of use of the data from a regulatory perspective for each experimental entry.
000121236 536__ $$9info:eu-repo/grantAgreement/EC/H2020/814426/EU/Development and Implementation of a Sustainable Modelling Platform for NanoInformatics/NanoInformaTIX$$9This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No H2020 814426-NanoInformaTIX
000121236 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/
000121236 590__ $$a10.0$$b2022
000121236 592__ $$a1.805$$b2022
000121236 591__ $$aTOXICOLOGY$$b4 / 94 = 0.043$$c2022$$dQ1$$eT1
000121236 593__ $$aHealth, Toxicology and Mutagenesis$$c2022$$dQ1
000121236 593__ $$aToxicology$$c2022$$dQ1
000121236 593__ $$aMedicine (miscellaneous)$$c2022$$dQ1
000121236 594__ $$a13.5$$b2022
000121236 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000121236 700__ $$aBurgum, Michael J.
000121236 700__ $$aSuárez-Merino, Blanca
000121236 700__ $$aClift, Martin J. D.
000121236 700__ $$aDoak, Shareen H.
000121236 700__ $$0(orcid)0000-0003-2936-242X$$aCatalán, Julia$$uUniversidad de Zaragoza
000121236 7102_ $$11001$$2420$$aUniversidad de Zaragoza$$bDpto. Anatom.,Embri.Genét.Ani.$$cÁrea Genética
000121236 773__ $$g19 (2022), 59 [24 pp.]$$pPart fibre toxicol.$$tPARTICLE AND FIBRE TOXICOLOGY$$x1743-8977
000121236 8564_ $$s2501626$$uhttps://zaguan.unizar.es/record/121236/files/texto_completo.pdf$$yVersión publicada
000121236 8564_ $$s2456909$$uhttps://zaguan.unizar.es/record/121236/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000121236 909CO $$ooai:zaguan.unizar.es:121236$$particulos$$pdriver
000121236 951__ $$a2024-03-18-16:32:39
000121236 980__ $$aARTICLE