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Abstract: Carcinogenic chemicals, or their metabolites, can be classified as genotoxic or non-genotoxic carcinogens (NGTxCs). Genotoxic compounds induce DNA damage, which can be detected by an established in vitro and in vivo battery of genotoxicity assays. For NGTxCs, DNA is not the primary target, and the possible modes of action (MoA) of NGTxCs are much more diverse than those of genotoxic compounds, and there is no specific in vitro assay for detecting NGTxCs. Therefore, the evaluation of the carcinogenic potential is still dependent on long-term studies in rodents. This 2-year bioassay, mainly applied for testing agrochemicals and pharmaceuticals, is time-consuming, costly and requires very high numbers of animals. More importantly, its relevance for human risk assessment is questionable due to the limited predictivity for human cancer risk, especially with regard to NGTxCs. Thus, there is an urgent need for a transition to new approach methodologies (NAMs), integrating human-relevant in vitro assays and in silico tools that better exploit the current knowledge of the multiple processes involved in carcinogenesis into a modern safety assessment toolbox. Here, we describe an integrative project that aims to use a variety of novel approaches to detect the carcinogenic potential of NGTxCs based on different mechanisms and pathways involved in carcinogenesis. The aim of this project is to contribute suitable assays for the safety assessment toolbox for an efficient and improved, internationally recognized hazard assessment of NGTxCs, and ultimately to contribute to reliable mechanism-based next-generation risk assessment for chemical carcinogens.
Keywords: non-genotoxic carcinogens, NGTxC, new approach methodologies, NAM, PARC
Published in DiRROS: 05.08.2024; Views: 85; Downloads: 47
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Abstract: The Adriatic-Ionian region (ADRION Region) shows strong development in terms of urban expansion in coastal and inland areas as well as increasing maritime traffic and offshore hydrocarbon extraction activities. A serious risk of pollution arises from hazardous substances requiring reliable and coherent monitoring and assessment programs. EU Directives (WFD – Water Framework Directive, MSFD – Marine Strategy Framework Directive) and Barcelona Convention protocols, aim to assess the level of pollution with the objective to implement measures to prevent and/or mitigate impacts on the marine environment. This high level integration process has to be based on common and agreed protocols for monitoring of contaminants. Aiming to share best practices to encourage a harmonized implementation of monitoring and assessment of contaminants, an extensive review of monitoring and analytical protocols adopted by six EU and non-EU countries along the Adriatic and Ionian seas was carried out in the framework of the Interreg Adrion project HarmoNIA (Interreg V-B Adriatic-Ionian (ADRION), 2018–2020). This paper presents a methodological proposal to define a common protocol for the evaluation of the metal contamination of seawater, sediment and biota. Contaminants have been chosen following preliminary consultations among countries of the ADRION area, considering objectives of WFD and MSFD, as well as Environmental Impact Assessment (EIA) procedures for offshore platforms. Information was gathered relative to matrix characteristics and quality assurance/quality control of the analytical performance (sample preservation, analytical methodology, reference materials, limit of detection, and limit of quantification, accuracy, reproducibility, etc.). The comparison of information provided by laboratories of nine institutions highlighted the request for harmonization in terms of sampling procedures, matrix characterization, preservation procedures, analytical methods and LOQ values. Although appropriate environmental quality standards for biota and sediment matrices should be established at national level and also through regional and sub-regional cooperation, as required by the WFD and MSFD, the proposed LOQ values, even if challenging, represent a benchmark and a stimulus to optimize analytical performance, to ensure the best level of protection to the coastal and offshore environment in the ADRION Region.
Keywords: hazardous substances, harmonized protocols, integrated approach, monitoring, assessment of contaminants, heavy metals, Adriatic-Ionian Sea region
Published in DiRROS: 22.07.2024; Views: 215; Downloads: 131
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Abstract: One of the common European commitments is a transition towards a green circular economy in which waste is not discarded and considered to be just an environmental problem, but should be recognized as an important potential source of raw materials for industry. In a priority order in waste management activities, introduced by the Waste Directive in 2012, recycling is set just behind the waste prevention and reuse. Many types of waste can be recycled, the most perspective being construction, industrial and mining wastes. The latter are produced and disposed of at mine sites during the excavation and processing of ore and are extremely perspective due to large quantities and remaining of different metals, however still underutilized, with low recycling rate. Many mining wastes are inert and do not releases contaminants into environment, however, some of them are problematic and even require monitoring. Reprocessing of these wastes, which include beneficiation and sequential extraction of valuable metals in the first phase and recycling of residues in both structural and civil engineering in the second phase establishes a zero waste model with several benefits for economy, environment and society. Out of the South-East European countries, North Macedonia has great potential to establish this model. As a consequence of long mining tradition and abundant ore resources, there are many mining and metallurgical tailings, on the other hand vivid economy and numerous sinks for use of recycled materials in construction sector can accommodate these quantities. However, there are open questions in terms of administrative procedures and legislation. What are those obstacles that accompany the smooth establishment of the proposed model from a legislative point of view? This paper deals with the situation in North Macedonia, in terms of opportunities, legislative options and the need to adopt new legislation, taking also into account the current problems in this field in Europe.
Keywords: circular economy, zero-waste approach, mining waste, construction sector, legislation, krožno gospodarstvo, pristop ničelnega odpadka, rudarski odpadki, gradbeništvo, zakonodaja
Published in DiRROS: 04.12.2023; Views: 404; Downloads: 199
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Abstract: Adolescents present a relevant stakeholder in international migrations since they comprise a large share of all migrants. Previous studies show that migration processes significantly affect the well-being of migrant adolescents. This article investigates how the school environment, with its pedagogical practices and interpersonal relationships established between migrant adolescents, their classmates, and teachers, affect migrant adolescents’ well-being. Our research draws on quantitative data collected as part of the MiCREATE project. The sample of migrant adolescents (N = 700) was surveyed in 46 schools in six countries: Austria, Denmark, Slovenia, Spain, Poland, and the United Kingdom. Results indicate that migrant adolescents like school and feel safe there, however, they tend to be more satisfied with relationships established with teachers than with peers. Furthermore, differences in self-perceived school well-being emerge when comparing countries with a longer tradition of high migration flows (Spain, Denmark, and the United Kingdom) and those less experienced (Poland and Slovenia), although slight exceptions were detected. The results lead to the conclusion that schools that foster intercultural education and fulfilling interpersonal relationships are essential for school well-being of migrant adolescents and present an important step toward successful integration of migrant youth.
Keywords: migration, migrant children, well-being, integration, child-centered approach, family, school
Published in DiRROS: 30.01.2023; Views: 486; Downloads: 306
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Abstract: Background: Vismodegib is a first-in-class inhibitor of the hedgehog pathway for treatment of locally advanced basal cell carcinoma (laBCC) and metastatic BCC. Objectives: The purpose of this study is to report outcomes of patients with laBCC, with basal cell carcinoma nevus syndrome (Gorlin Goltz syndrome [G-G Syn]) treated with vismodegib in routine clinical practice in Slovenia in 8.3-year period. Methods: In this retrospective cohort study, we analyzed baseline characteristics, outcomes, and treatment-related adverse events from locally advanced BCC. The patients were divided into two cohorts: 39 laBCC or multiple BCC patients and 7 patients with G-G Syn who were treated with vismodegib from November 2012 till January 2021. Results: During 100-month period, 46 patients were diagnosed with laBCC (26), multiple BCC (13), and G-G Syn (7), all inappropriate for surgery or radiotherapy. Baseline characteristics: median age was 72.8 years in laBCC + multiple BCC cohort and 47.4 years in G-G Syn cohort. The objective response rate was 80% in laBCC + multiple BCC and 86% in G-G Syn cohort. Disease control rate (DCR) was 95% in laBCC + multiple BCC and 100% in G-G Syn cohort. Median duration of treatment was 9.9 months (range: 1.5-43.1) in laBCC and multiple BCC cohort and 19.5 months (range: 3.6-94.1) in G-G Syn cohort. Majority of treatment-emergent adverse events (TEAEs) in laBCC or multiple BCC cohort were grade 1 or 2 (96%), only 4% of AEs were grade 3. Majority of TEAEs in G-G Syn cohort were also grade 1 or 2 (87%), 13% of AEs were grade 3. No grade 4 or 5 vismodegib-related AEs were reported. Conclusion: Vismodegib has shown meaningful efficacy with DCR from 95% to 100% in patients with laBCC, multiple BCC, and G-G Syn in Slovenia. TEAEs were successfully alleviated with multidisciplinary approach and early supportive care.
Keywords: basal cell carcinoma, early supportive care, Gorlin Goltz syndrome, multidisciplinary approach
Published in DiRROS: 07.09.2022; Views: 583; Downloads: 294
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