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Found 8 publications. Showing page 1 of 1:

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New Approach Methods (NAMs) for genotoxicity assessment of nano- and advanced materials; Advantages and challenges

Gutleb, Arno; Murugadoss, Sivakumar; Stepnik, Maciej; SenGupta, Tanima; El Yamani, Naouale; Longhin, Eleonora Marta; Olsen, Ann-Karin Hardie; Wyrzykowska, Ewelina; Jagiello, Karolina; Judzinska, Beata; Cambier, Sebastien; Honza, Tatiana; McFadden, Erin; Shaposhnikov, Sergey; Puzyn, Tomasz; Serchi, Tommaso; Weber, Pamina; Arnesdotter, Emma; Skakalova, Vier; Jirsova, Katerina; Grudzinski, Ireneusz; Collins, Andrew; Rundén-Pran, Elise; Dusinska, Maria

Genotoxicity assessment is essential for ensuring chemical safety and mitigating risks to human health and the environment. Traditional methods, reliant on animal models, are time-consuming, costly, and raise ethical concerns. New Approach Methods (NAMs) offer innovative, cost-effective, and ethical alternatives, playing a pivotal role in both traditional and next-generation risk assessment (NGRA) by minimizing the need for animal testing, particularly in genotoxicity evaluations. However, the development of NAMs often overlooks the particular physicochemical properties of nanomaterials (NMs), which significantly influence their toxicological behaviour and can interfere with genotoxicity evaluation. This underscores an urgent need for the standardization and adaptation of NAMs to address nano- and advanced material-specific genotoxicity challenges. In this review, we summarize the challenges associated with genotoxicity testing of NMs and highlight the suitability of existing in vitro and in silico NAMs for NMs and advanced materials, enabling genotoxicity testing across various exposure routes and organ systems. Despite considerable progress, regulatory validation remains constrained by the absence of approved test guidelines and standardized protocols. To achieve regulatory acceptance, it is crucial to adapt NAMs to NM-specific exposure scenarios, refine test systems to better mimic human biology, develop tailored in vitro protocols, and ensure thorough characterisation of NMs both in pristine form and dispersed in culture medium. Collaborative efforts among scientists, regulators, industry, and advocacy groups are vital to improving the reliability and regulatory acceptance of NAMs. By addressing these challenges, NAMs have the potential to revolutionize genotoxicity risk assessment, advancing it towards a more sustainable, efficient and ethical framework.

2025

Hazard characterization of the mycotoxins enniatins and beauvericin to identify data gaps and improve risk assessment for human health

Behr, Anne-Cathrin; Fæste, Christiane Kruse; Azqueta, Amaya; Tavares, Ana M.; Spyropoulou, Anastasia; Solhaug, Anita; Olsen, Ann-Karin Hardie; Vettorazzi, Ariane; Mertens, Birgit; Zegura, Bojana; Streel, Camille; Ndiaye, Dieynaba; Spilioti, Eliana; Dubreil, Estelle; Buratti, Franca Maria; Crudo, Francesco; Eriksen, Gunnar Sundstøl; Snapkov, Igor; Teixeira, João Paulo; Rasinger, Josef; Sanders, Julie; Machera, Kyriaki; Ivanova, Lada; Gaté, Laurent; Le Hegarat, Ludovic; Novak, Matjaz; Smith, Nicola Margareta; Tait, Sabrina; Fraga, Sónia; Hager, Sonja; Marko, Doris; Braeuning, Albert; Louro, Henriqueta; Silva, Maria João; Dirven, Hubert; Dietrich, Jessica

Enniatins (ENNs) and beauvericin (BEA) are cyclic hexadepsipeptide fungal metabolites which have demonstrated antibiotic, antimycotic, and insecticidal activities. The substantial toxic potentials of these mycotoxins are associated with their ionophoric molecular properties and relatively high lipophilicities. ENNs occur extensively in grain and grain-derived products and are considered a food safety issue by the European Food Safety Authority (EFSA). The tolerable daily intake and maximum levels for ENNs in humans and animals remain unestablished due to key toxicological and toxicokinetic data gaps, preventing full risk assessment. Aiming to find critical data gaps impeding hazard characterization and risk evaluation, this review presents a comprehensive summary of the existing information from in vitro and in vivo studies on toxicokinetic characteristics and cytotoxic, genotoxic, immunotoxic, endocrine, reproductive and developmental effects of the most prevalent ENN analogues (ENN A, A1, B, B1) and BEA. The missing information identified showed that additional studies on ENNs and BEA have to be performed before sufficient data for an in-depth hazard characterisation of these mycotoxins become available.

Springer

2025

Dust in the arctic: a brief review of feedbacks and interactions between climate change, aeolian dust and ecosystems

Meinander, Outi; Uppstu, Andreas; Dagsson-Waldhauserova, Pavla; Zwaaftink, Christine Groot; Jørgensen, Christian Juncher; Baklanov, Alexander; Kristensson, Adam; Massling, Andreas; Sofiev, Mikhail

Climatic feedbacks and ecosystem impacts related to dust in the Arctic include direct radiative forcing (absorption and scattering), indirect radiative forcing (via clouds and cryosphere), semi-direct effects of dust on meteorological parameters, effects on atmospheric chemistry, as well as impacts on terrestrial, marine, freshwater, and cryospheric ecosystems. This review discusses our recent understanding on dust emissions and their long-range transport routes, deposition, and ecosystem effects in the Arctic. Furthermore, it demonstrates feedback mechanisms and interactions between climate change, atmospheric dust, and Arctic ecosystems.

Frontiers Media S.A.

2025

Overview of methods for production of sterile salmonids, their applicability in aquaculture and possible implications to wild salmon populations and biodiversity in Norway

Hindar, Kjetil; Bodin, Johanna Eva; Dalen, Knut Tomas; Duale, Nur; Garseth, Åse Helen; Malmstrøm, Martin; Sipinen, Ville Erling; Thorstad, Eva Bonsak; Velle, Gaute; Berg, Paul Ragnar; Mo, Tor-Atle; Olesen, Ingrid; Olsen, Ann-Karin Hardie; Rimstad, Espen

VKM has assessed the positive and negative effects on biodiversity were sterile salmon to be used in Norwegian aquaculture. Triploidisation is assessed as the most effective method for sterilising fish, but it can affect the welfare and health of the fish.

Several other techniques for producing sterile salmon are being tested, but it is too early to determine whether they can be used in large-scale farming.

This is the key message in a knowledge summary VKM has prepared for the Norwegian Environment Agency.

Background
Escaped farmed salmon poses a major threat to wild salmon in Norway. hey can interbreed with wild salmon, genetically alter them, and make the populations less adaptable and more vulnerable to disease and environmental changes. A possible solution to the problem may be to use sterile salmon in farming.

To date, only triploidisation has been tested. Newly fertilised eggs are given a hydrostatic pressure shock, thereby retaining an extra set of chromosomes which render the fish sterile. This method is currently the only one tested on a large scale. Triploidisation is effective but can also pose health and welfare challenges to fish.

Methods
VKM has reviewed available scientific literature regarding methods that can be used to produce sterile salmon. VKM has assessed whether these methods work as well, or better, than triploidy and whether they are likely to have fewer negative effects on fish welfare. Assessments have also been made of whether farmed fish treated with other sterilisation methods pose a greater or lesser threat to wild salmon than traditional farmed salmon.

VKM has looked at the possibilities for further development of the triploidisation technique and has also assessed various methods currently being tested for producing sterile fish. Some of these are still at the laboratory-testing stage, while others are approaching trials with release into sea-pens. VKM has grouped the different methods based on whether they cause permanent changes in the genome (so-called "knock-out" of important genes) or whether the changes only result in temporary blocking or downregulation of gene expression (so-called "knock-down").

Results
VKM concludes that triploidisation remains the most effective method and that there are possibilities to further develop this methodology through targeted breeding and adjustments in how the fish are kept. These measures can potentially solve the challenges for fish health and welfare. Using pure triploid female lines can also reduce some of the other challenges by preventing spawning interactions in rivers and reducing disease transmission to wild salmon.

Alternative sterilisation methods, such as gene editing, vaccination, and temporary downregulation of proteins for gonad development using antisense oligomers and egg immersion, are promising but still under development.

VKM assesses that methods causing permanent changes in the genome of diploid fish have a higher inherent risk than methods that only affect gene expression.

Hope in egg-bathing
Perhaps the most promising technique for safe production of sterile salmon is to add synthetic oligonucleotides to the eggs at an early stage, thereby preventing germ cell development without causing any inheritable changes. Such oligonucleotides can be injected into the eggs or absorbed by the eggs through bathing (immersion) in a special solution.

"Especially the method involving targeted 'tools,' such as oligonucleotides that prevent germ cell development and can be added to the eggs in a water bath, seems promising," says Johanna Bodin, member of the Panel for Genetically Modified organisms and spokesperson for the report.

(...)

2025

A critical review to identify data gaps and improve risk assessment of bisphenol A alternatives for human health

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; João Silva, Maria

Bisphenol 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).

Informa Healthcare

2024

Cross-cutting studies of per- and polyfluorinated alkyl substances (PFAS) in Arctic wildlife and humans

Lohmann, Rainer; Abass, Khaled; Bonefeld-Jørgensen, Eva Cecilie; Bossi, Rossana; Dietz, Rune; Ferguson, Steve; Fernie, Kim J.; Grandjean, Philippe; Herzke, Dorte; Houde, Magali; Lemire, Mélanie; Letcher, Robert J.; Muir, Derek; De Silva, Amila O.; Ostertag, Sonja K.; Rand, Amy A.; Søndergaard, Jens; Sonne, Christian; Sunderland, Elsie M.; Vorkamp, Katrin; Wilson, Simon; Weihe, Pal

This cross-cutting review focuses on the presence and impacts of per- and polyfluoroalkyl substances (PFAS) in the Arctic. Several PFAS undergo long-range transport via atmospheric (volatile polyfluorinated compounds) and oceanic pathways (perfluorinated alkyl acids, PFAAs), causing widespread contamination of the Arctic. Beyond targeting a few well-known PFAS, applying sum parameters, suspect and non-targeted screening are promising approaches to elucidate predominant sources, transport, and pathways of PFAS in the Arctic environment, wildlife, and humans, and establish their time-trends. Across wildlife species, concentrations were dominated by perfluorooctane sulfonic acid (PFOS), followed by perfluorononanoic acid (PFNA); highest concentrations were present in mammalian livers and bird eggs. Time trends were similar for East Greenland ringed seals (Pusa hispida) and polar bears (Ursus maritimus). In polar bears, PFOS concentrations increased from the 1980s to 2006, with a secondary peak in 2014–2021, while PFNA increased regularly in the Canadian and Greenlandic ringed seals and polar bear livers. Human time trends vary regionally (though lacking for the Russian Arctic), and to the extent local Arctic human populations rely on traditional wildlife diets, such as marine mammals. Arctic human cohort studies implied that several PFAAs are immunotoxic, carcinogenic or contribute to carcinogenicity, and affect the reproductive, endocrine and cardiometabolic systems. Physiological, endocrine, and reproductive effects linked to PFAS exposure were largely similar among humans, polar bears, and Arctic seabirds. For most polar bear subpopulations across the Arctic, modeled serum concentrations exceeded PFOS levels in human populations, several of which already exceeded the established immunotoxic thresholds for the most severe risk category. Data is typically limited to the western Arctic region and populations. Monitoring of legacy and novel PFAS across the entire Arctic region, combined with proactive community engagement and international restrictions on PFAS production remain critical to mitigate PFAS exposure and its health impacts in the Arctic.

Elsevier

2024

Zürich II Statement on Per- and Polyfluoroalkyl Substances (PFASs): Scientific and Regulatory Needs

DeWitt, Jamie C.; Glüge, Juliane; Cousins, Ian T.; Goldenman, Gretta; Herzke, Dorte; Lohmann, Rainer; Miller, Mark; Ng, Carla A.; Patton, Sharyle; Trier, Xenia; Vierke, Lena; Wang, Zhanyun; Adu-Kumi, Sam; Balan, Simona; Buser, Andreas M.; Fletcher, Tony; Haug, Line Småstuen; Heggelund, Audun; Huang, Jun; Kaserzon, Sarit; Leonel, Juliana; Sheriff, Ishmail; Shi, Ya-Li; Valsecchi, Sara; Scheringer, Martin

Per- and polyfluoroalkyl substances (PFASs) are a class of synthetic organic chemicals of global concern. A group of 36 scientists and regulators from 18 countries held a hybrid workshop in 2022 in Zürich, Switzerland. The workshop, a sequel to a previous Zürich workshop held in 2017, deliberated on progress in the last five years and discussed further needs for cooperative scientific research and regulatory action on PFASs. This review reflects discussion and insights gained during and after this workshop and summarizes key signs of progress in science and policy, ongoing critical issues to be addressed, and possible ways forward. Some key take home messages include: 1) understanding of human health effects continues to develop dramatically, 2) regulatory guidelines continue to drop, 3) better understanding of emissions and contamination levels is needed in more parts of the world, 4) analytical methods, while improving, still only cover around 50 PFASs, and 5) discussions of how to group PFASs for regulation (including subgroupings) have gathered momentum with several jurisdictions proposing restricting a large proportion of PFAS uses. It was concluded that more multi-group exchanges are needed in the future and that there should be a greater diversity of participants at future workshops.

American Chemical Society (ACS)

2024

Troll observing network – for useful new data about Antarctica

Pedersen, Christina Alsvik; Njåstad, Birgit; Descamps, Sebastien; Hattermann, Tore; Hudson, Stephen; Flått, Stig; Tronstad, Stein; Aas, Wenche; Darelius, Elin Maria K.; Miloch, Wojciech Jacek; Schweitzer, Johannes; Storvold, Rune

What do Antarctic petrels in Svarthamaren, soil structure movements at Troll research station and ocean chemistry in the Håkon VII Sea have in common? They will all be studied at the Troll observing network currently being established at Troll research station in Dronning Maud Land in Antarctica.

2023

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