Percorrer por autor "El Yamani, Naouale"
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- Contribution to the hazard assessment of benchmark metallic nanomaterials through a set of in vitro genotoxicity assaysPublication . Vital, Nádia; El Yamani, Naouale; Pinhão, Mariana; Rúden-Pra, Elise; Louro, Henriqueta; Dušinská, Maria; Silva, Maria JoãoMetallic nanomaterials are among the most commonly applied manufactured nanomaterials (NM). Regardless of the considerable efforts to assess their safety, the presently available data do not allow for general and consistent conclusions. Moreover, the validity of the classical in vitro testing systems for NMs hazard assessment has been questioned and needs confirmation. In the present study, the toxicity of three benchmark metallic NMs, including two insoluble NMs - titanium (NM-100) and cerium (NM-212) dioxides - and soluble silver nanorods/wires (NM-302) was investigated. A panel of in vitro genotoxicity tests that analyze different endpoints was applied and the physico-chemical properties of each NM were considered.
- Contribution to the hazard assessment of benchmark metallic nanomaterials through a set of in vitro genotoxicity assaysPublication . Vital, Nádia; El Yamani, Naouale; Pinhão, Mariana; Rúden-Pra, Elise; Louro, Henriqueta; Dušinská, Maria; Silva, Maria JoãoBackground and Aim: Metall-based nanomaterials (NMs) are among the most commonly applied manufactured nanomaterials (NM). Regardless of the considerable efforts to assess their safety, the presently available data do not allow for general and consistent conclusions. Moreover, the validity of the classical in vitro testing systems for NMs hazard assessment has been questioned and needs confirmation. The present study aimed at evaluating the toxicity of three benchmark metallic NMs - titanium dioxide (NM-100),cerium dioxide (NM-212) and nanosilver - with different physicochemical properties, using a battery of in vitro genotoxicity assays, in an attempt to characterize their toxicity profile.
- A critical review to identify data gaps and improve risk assessment of bisphenol A alternatives for human healthPublication . Mhaouty-Kodja, Sakina; Zalko, Daniel; Tait, Sabrina; Testai, Emanuela; Viguié, Catherine; Corsini, Emanuela; Grova, Nathalie; Buratti, Franca Maria; Cabaton, Nicolas J.; Coppola, Lucia; De la Vieja, Antonio; Dusinska, Maria; El Yamani, Naouale; Galbiati, Valentina; Iglesias-Hernández, Patricia; Kohl, Yvonne; Maddalon, Ambra; Marcon, Francesca; Naulé, Lydie; Rundén-Pran, Elise; Salani, Francesca; Santori, Nicoletta; Torres-Ruiz, Mónica; Turner, Jonathan D.; Adamovsky, Ondrej; Aiello-Holden, Kiara; Dirven, Hubert; Louro, Henriqueta; Silva, Maria JoãoBisphenol A (BPA), a synthetic chemical widely used in the production of polycarbonate plastic and epoxy resins, has been associated with a variety of adverse effects in humans including metabolic, immunological, reproductive, and neurodevelopmental effects, raising concern about its health impact. In the EU, it has been classified as toxic to reproduction and as an endocrine disruptor and was thus included in the candidate list of substances of very high concern (SVHC). On this basis, its use has been banned or restricted in some products. As a consequence, industries turned to bisphenol alternatives, such as bisphenol S (BPS) and bisphenol F (BPF), which are now found in various consumer products, as well as in human matrices at a global scale. However, due to their toxicity, these two bisphenols are in the process of being regulated. Other BPA alternatives, whose potential toxicity remains largely unknown due to a knowledge gap, have also started to be used in manufacturing processes. The gradual restriction of the use of BPA underscores the importance of understanding the potential risks associated with its alternatives to avoid regrettable substitutions. This review aims to summarize the current knowledge on the potential hazards related to BPA alternatives prioritized by European Regulatory Agencies based on their regulatory relevance and selected to be studied under the European Partnership for the Assessment of Risks from Chemicals (PARC): BPE, BPAP, BPP, BPZ, BPS-MAE, and TCBPA. The focus is on data related to toxicokinetic, endocrine disruption, immunotoxicity, developmental neurotoxicity, and genotoxicity/carcinogenicity, which were considered the most relevant endpoints to assess the hazard related to those substances. The goal here is to identify the data gaps in BPA alternatives toxicology and hence formulate the future directions that will be taken in the frame of the PARC project, which seeks also to enhance chemical risk assessment methodologies using new approach methodologies (NAMs).
- Mutagenic and carcinogenic potential of metal nanoparticles depends on their physicochemical propertiesPublication . Dusinska, Maria; El Yamani, Naouale; Fjellsbø, Lise Maria; Huk, Anna; Gabelova, Alena; Alonso, Tamara Iglesias; Silva, Maria João; Pran, Elise RundenNanomaterials (NMs) and nanoparticles (NPs) have been studied intensively for almost two decades and still all the characteristics that might be beneficial or harmful are not explored. Although many studies have investigated the mechanisms of action of NPs in cells, results are not fully understood and in many cases are controversial. Endpoints appropriate for detecting harmful chemicals such as cytotoxicity, oxidative stress, inflammation, immunotoxicity, genotoxicity, and in some cases carcinogenicity, have been addressed. However, there might be also new mechanisms that might lead to NM-induced toxic effects.
- A regulatory perspective on the applicability of NAMs in genotoxicity and carcinogenicity assessment in EU: current practices and future directionsPublication . Bossa, Cecilia; Alivernini, Silvia; Andreoli, Cristina; Aquilina, Gabriele; Attias, Leonello; Benfenati, Emilio; Dusinska, Maria; El Yamani, Naouale; Louro, Henriqueta; Marcon, Francesca; Raitano, Giuseppa; Rundén-Pran, Elise; Russo, Maria Teresa; Silva, Maria João; Battistelli, Chiara LauraNew Approach Methodologies (NAMs) are gaining significant momentum globally to reduce animal testing and enhance the efficiency and human relevance of chemical safety assessment. Even with substantial EU commitment from regulatory agencies and the academic community, the full regulatory adoption of NAMs remains a distant prospect. This challenge is further complicated by the fact that the academic world, oriented toward NAMs development, and regulatory agencies, focused on practical application, frequently operate in separate spheres. Addressing this disconnect, the present paper, developed within the European Partnership for the Assessment of Risks from Chemicals (PARC), provides a clear overview of both the available non-animal tests and current evaluation practices for genotoxic and carcinogenic hazard assessment, while simultaneously highlighting existing regulatory needs, gaps, and challenges toward greater human health protection and the replacement of animal testing through NAMs adoption. The analysis reveals a complex landscape: while the EU is deeply committed to developing and adopting NAMs, as outlined in its Chemical Strategy for Sustainability and supported by initiatives like PARC, prescriptive regulations such as Classification, Labelling and Packaging (CLP) and Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) still heavily mandate in vivo animal data for hazard classification, particularly for germ cell mutagenicity and carcinogenicity. This reliance creates a "too-short-blanket-problem," where efforts to reduce animal testing may impact human health protection because of the current in vivo-based classification criteria. In contrast, sectors such as cosmetics and certain European Food Safety Authority (EFSA)-regulated products demonstrate greater flexibility toward progressive integration of NAMs. While the deep mechanistic understanding of genotoxicity and carcinogenicity has significantly advanced the integration of alternatives to animal tests into regulatory chemical hazard assessment, their broader and full implementation faces considerable challenges due to both scientific complexities (i.e., the development and validation of fit-for-purpose NAMs) and existing legislative provisions.