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- Talc and AcrylonitrilePublication . IARC Working Group on the Identification of Carcinogenic Hazards to HumansThis volume of the IARC Monographs provides evaluations of the carcinogenicity of talc and acrylonitrile. Talc was defined as mineral (natural) or synthetic product, a hydrated magnesium silicate, that exists in both lamellar and fibrous (including asbestiform) types. Asbestiform talc is not asbestos; however, asbestos is present in some talc deposits and has been shown to contaminate some talc products. A mineral with a high production volume, talc is used in plastics, ceramics, paint, paper, roofing materials, rubber products, animal feed, food, fertilizers, cosmetics, and pharmaceuticals. It is also used in clinical settings for pleurodesis. Occupational exposure to talc dust occurs predominantly during mining and milling, mainly via inhalation, but can also occur among workers in downstream industries. The general population may be exposed via talc-based consumer products, and pathways of exposure include ingestion, inhalation, and dermal contact, including via the perineum. Acrylonitrile is a chemical with a high production volume that is mostly used as a monomer to prepare polymers for the manufacture of fibres for textiles (acrylic fibres) used in clothing and carpets and other textiles, resins, synthetic rubber, and plastics. Occupational exposure occurs mainly in production industries via inhalation and dermal routes. The general population can be exposed to acrylonitrile via cigarette smoking, air pollution, and contact with contaminated consumer products. An IARC Monographs Working Group reviewed evidence from epidemiological studies, cancer bioassays in experimental animals, and mechanistic studies to assess the carcinogenic hazard to humans of exposure to these agents and concluded that: - Talc is probably carcinogenic to humans (Group 2A); - Acrylonitrile is carcinogenic to humans (Group 1).
- Analysis and evaluation of genotoxicity and carcinogenicity assessment in EU legislation to improve regulatory implementation of NAMs: A focus on in silico approachesPublication . Bossa, Cecília; Raitano, Giuseppa; Benfenati, Emilio; Alivernini, Silvia; Andreoli, Cristina; Aquilina, G.; Attias, L.; Dusinska, Maria; El Yamani, N.; Louro, Henriqueta; Marcon, Francesca; Rundèn-Pran, E.; Russo, Maria Teresa; Silva, Maria João; Battistelli, Chiara LauraGenotoxicity and carcinogenicity are key endpoints for the risk assessment of all types of substances. Research on alternatives to animal testing for these endpoints has been active for decades, leading to the development of short-term in vitro tests that are integrated into current testing strategies. Nevertheless, high relevance is still devoted to data from in vivo studies. In parallel, progress in the comprehension of mechanisms underpinning genotoxicity and genotoxic carcinogenicity processes, together with the analysis of the great wealth of experimental data produced, allowed the discovery of structural determinants utilized in quantitative and qualitative structure-activity relationships and enabling in silico predictions of these endpoints. Presented here is a case study part of the collective effort carried out within the European Partnership for the Assessment of Risks from Chemicals (PARC) to address the challenges associated with innovation in chemical risk assessment, including the phasing out of animal testing through the introduction of New Approach Methodologies (NAMs) [1,2]. The case study aims to analyze current practices of the regulatory evaluation of genotoxicity and carcinogenicity hazard in several EU frameworks, in order to highlight needs and challenges in the actual or potential use of NAMs as well as short-and long- term goals towards the overcoming of animal testing. Among other NAMs, we are focusing on the role of in silico approaches highlighting strategies to increase the regulatory application and acceptance of QSAR based approaches. To this aim, the OECD QSAR Assessment Framework [3,4] has been identified as a suitable tool for evaluating the models and their predictions and will be applied to selected case studies. Moreover, a list of human relevant carcinogens has been developed as reference chemicals to evaluate and possibly refine in silico methodologies supporting a human-centric paradigm shift in toxicology.
- European Deprivation Index and children with Cerebral Palsy: Data from the Portuguese Cerebral Palsy Surveillance ProgramPublication . Folha, Teresa; Cadete, Ana; Sousa-Uva, Mafalda; Aniceto, Carlos; Braz, Paula; Calado, Eulália; Alvarelhão, Joaquim; Virella, DanielIntroduction: Socioeconomic inequalities have been associated with the severity of cerebral palsy (CP). The European Deprivation Index (EDI) accounts for aggregated ecological effects not yet identified. We describe the association between complexity and etiology of CP and a proxy for socioeconomic inequalities in Portugal. Participants and Methods: The Portuguese National Surveillance of Cerebral Palsy (PNSCP) collects data of 5-to-8-year-old children with CP, born since 2001, following the Surveillance of Cerebral Palsy in Europe (SCPE) datacollection protocol. Official live-birth (LB) statistics and data from children with CP born between 2001-2015, notified until September 2024, were analysed according to the area-level socioeconomic deprivation at birth, using the Portuguese version of the EDI (EDI-PT), categorized in tertiles and measured at municipal level. The CP severity/complexity was classified using the Cerebral Palsy Complexity-Scale (CPC-Scale). Associations were estimated by the odds ratio (OR) with a 95% confidence interval (95%CI). Results: 2,410 registered children with CP were classified according to tertiles of EDI-PT: 481 children in the 1st tertile (20%-CP vs 23%-LB); 591 in the 2nd (25%-CP vs 33%-LB) and 1,338 in the 3d (55%-CP vs 44% LB). Significant associations were observed between the 3rd tertile of EDI-PT and both post-neonatal causes of CP (OR 2.365; CI 1.408, 4.175) and the complexity of CP (OR 1.355; CI 1.029, 1.782). Conclusion: Area-level socioeconomic disadvantage at birth appears to have a positive effect on the odds for more severe/complex CP and the occurrence of post-neonatal cases of CP. Further investigation is needed to better understand these associations.
- Congenital Anomalies and Cerebral Palsy: Data from the Portuguese Cerebral Palsy Surveillance ProgramPublication . Cadete, Ana; Folha, Teresa; Braz, Paula; Calado, Eulália; Alvarelhão, Joaquim; Virella, DanielBackground and Objectives: Attention was recently drawn to the association of congenital anomalies (CA) with severity and complexity of cerebral palsy (CP). Evidence of this association is presented. Participants-Methods: The Portuguese National Surveillance of Cerebral Palsy (PNSCP) registers data of 5-to-8-year-old children with CP, born since 2001. The PNSCP follows the Surveillance of Cerebral Palsy in Europe (SCPE) common database protocol. Data were cross-referenced with the Portuguese National Registry of Congenital Anomalies. Children born between 2001-2015, notified until September 2024, were analyzed. CA were characterized according to ICD-10, following the EUROCAT criteria. Associations between the clinical forms of CP, complexity indicators and the presence of CA were explored. Results: Of 2251 registered children, 603 (27%; 95%CI 24.9-28.6) had at least one CA recorded; 228 children had multiple CA (10%; 95%CI 8.9-11.4). CA of the nervous system Q00-Q07 (CANS) are the most frequent (16%; 95%CI 14.9-18.0), followed by CA of the circulatory system Q20-Q28 (CACS) (4.9%; 95%CI 4.1-59). The odds of having at least one indicator of CP complexity increases by 2.6 times when having a CA (OR 2.6; 95%CI 2.01-3.48); slightly higher if a CANS exists (2.9; 95%CI 2.06-4,21), and slightly lower if a CACS exists (1.6; 95%CI 0.98-2.83). Conclusion: The prevalence of CA in children with CP is much higher than in the general population and increases the odds for greater severity and/or complexity of CP. The odds seems to be higher in the presence of CANS. This should be considered when assessing the prognosis and planning intervention.
- Ingested titanium dioxide nanomaterials: new approach to investigate intestinal genotoxicity and key cellular/molecular effectsPublication . Ventura, Célia; Rolo, Dora; Gramacho, Ana C.; Vieira, Adriana; Roque, Rossana; Valente, Ana; Vital, Nádia; Pinto, Fátima; Alvito, Paula; Assunção, Ricardo; Martins, Carla; Bettencourt, Ana; Gonçalves, Lídia; Pereira, Joana; Matos, Paulo; Jordan, Peter; Vieira, Luís; Silva, Catarina; Silva, Maria Joao; Louro, HenriquetaOral exposure to titanium dioxide nanomaterials (TiO2NMs) is due to their presence in food, food contact materials, medicines and cosmetics. The gastrointestinal tract(GIT) represents primary site of contact, that may result in systemic exposure, if biological barriers are surpassed. The INGESTnano project aimed to investigate nano-bio interactions at the cellular/molecular levels within the context of the intestinal tract and digestion processes, for understanding potential effects on human health. A group of three TiO₂NMs(NM-102, NM-103, NM-105) was selected as case study using a new approach methodology(NAM), incorporating the in vitro human digestion simulation prior to biological assays in Caco-2 and HT29-MTX-E12 intestinal cells. The endpoints included cyto- and genotoxicity, cell uptake, intestinal permeability, GIT transport and epigenomic modifications. The results showed a more pronounced cytotoxicity in HT29-MTX-E12 cells for digested NM-105, as compared to undigested, concomitantly with subtle changes in hydrodynamic-size. DNA-damage induction was more relevant for NM-105, and the micronucleus assay showed chromosomal damage in HT29-MTX-E12 cells for all TiO2NMs, especially after in vitro digestion.All NMs, digested or not, were internalized by intestinal cells, but did not affect transepithelial resistance, nor the epithelial markers in polarized enterocytes. NM-102 was retained in lysosomes, while NM-103 and NM-105 showed transcytosis, a potential gateway for systemic distribution. Using Reduced Representation Bisulfite Sequencing, several differentially methylated genes were identified for the TiO₂NMs, either digested or not. Pathway and Gene Ontology analyses showed that each TiO2NMs has a different functional impact on intestinal cells, probably linked to specific physicochemical properties, and digestion seems to reduce this impact. A trend towards CpG hypermethylation was observed upon NM-105 exposure, unlike for the other TiO2NMs. This integrated approach enabled the identification of key events and molecular pathways elicited by TiO2NMs, highlighting the importance of considering the digestion on the induction of adverse outcomes.
- Postneonatal Cerebral Palsy according to the new surveillance of Cerebral Palsy in Europe Classification: Data from the Portuguese Cerebral Palsy Surveillance ProgramPublication . Cadete, Ana; Folha, Teresa; Calado, Eulália; Alvarelhão, Joaquim; Gouveia, Rosa; Virella, DanielBackground and Objectives: The Portuguese National Surveillance of Cerebral Palsy Program (PNSCPP) registers clinical, epidemiological and functional data of children with cerebral palsy(CP) at 5-8 year old, born in the 21 st century, The Surveillance of Cerebral Palsy in Europe (SCPE) recently published the classification of primary events contributing to postneonatal cerebral palsy (CEC-PNCP) in whose validation process the PCPSP contributed with part of the cases reported. We propose to analyze all portugueses cases of post-neonatal cause, according to the SCPE (CPEC-PNCP). Participants and Methods: The PNSCPP uses multiple sources, following the common Surveillance of Cerebral Palsy in Europe (SCPE) protocol, including CP definition and classification, neuroimaging and associated impairments. Children with post-neonatal cause (PNCP) born between 2001-2015 and reported to the PVNPC between 2006-2024 at living in Portugal at 5-8 years were analysed acording the CEC-PNCP. Results: Were analysed 203 (9%) children with PNCP from a total of 2276. Age of injury between 1-59th month of life, almost (80%) up to 24th months. Applying the CPEC-PNCP, were classified according to the categories: A-Infections (CA-I) 84 cases (41%); 22 (11%) B-Traumatic Brain Injury (CBI-T); 44 (22%); C-Injury related to medical procedure (CC-IRMP), 30 (15%) D-Stroke (CD-CVA), 14 (7%); E-Hypoxic Brain Damaging (CE-HBD); 9 (4%) in class F-Miscellaneous (CF-M). Spastic Cerebral Palsy (SCP) was the most frequently recorded clinical type, ranging from 100% in CD-CVA to 84.1% in CA-I. Dyskinetic Cerebral Palsy (DCP) was more common in the CE- HBD (15.4%) and CA-I (13.4%), and Ataxic Cerebral Palsy (ACP) in CF-M (11.1%) (p0.102). The presence of any congenital anomaly (CA) was confirmed in 47/197 children (23.9%). CC- IRMP registed the highest proportion of CA (65.1%), followed by CD-CVA (33.3%) and CE- HBD (21.4%). The cardiac CA subtype (ICD-10-Q2) registed 46.5% in CC- IRMP and 0% in CB-TBI and CF-M. The class with the best functional record was CB-TBI (GMF-I-II: 63.7%); (BFMF-I-II 57.1%); The worst functional was CE- HBD (GMF-III-IV-V 90.9%) and (BFMF-III-IV-V 100%). Associated morbidity and school inclusion varied among the different categories. Conclusion: Children with CP-PNN differ greatly according to the CPEC-PNCP in terms of clinical type, functional skills. This classification allows a better characterization of the primary event contributing to post-neonatal etiopathological process, a better understanding and action in the rehabilitation and inclusion processes and provide an opportunity for preventive measures to be implemented.
- Low numbers of COVID-19 in the 2024/25 winter season: potential seasonality patternPublication . Rodrigues, Ana Paula; das Neves Pereira da Silva, SusanaBrief presentation analysing the possibility of a seasonal pattern of COVID-19 epidemics in Portugal, in the context of the VEBIS Annual Meeting.
- Efeito da interação entre calor extremo e poluição por partículas atmosféricas na mortalidade diária em Portugal continentalPublication . Canha, Filipa; Leite, Andreia; Silva, Susana; Gaio, VâniaIntrodução: O incremento da temperatura global e a poluição atmosférica no contexto das alterações climáticas representam riscos crescentes para a saúde. Os efeitos isolados destas exposições estão amplamente descritos, no entanto, apenas recentemente tem surgido evidência de efeito sinérgico entre calor e matéria particulada (PM, em inglês particulate matter). Este estudo teve como objetivos avaliar o efeito da interação entre calor extremo e poluição elevada por PM na mortalidade diária em Portugal continental e por distrito. Métodos: Análise de séries temporais em duas etapas para os verões (maio-setembro) de 2003 a 2023, utilizando dados diários da temperatura máxima, das concentrações médias de PM10 e PM2,5 separadamente, e da mortalidade por todas as causas em todos os distritos de Portugal continental. O calor extremo e a poluição elevada por PM foram definidos como valores acima do percentil 90 da sua distribuição. Para considerar os efeitos desfasados, utilizou-se a média móvel a 7 dias para as PM, e modelos não lineares com desfasamento distribuído, com um desfasamento de 10 dias, para a temperatura. Na primeira etapa, estimaram-se os riscos relativos cumulativos (RRc) da interação entre as exposições na mortalidade para cada distrito, correspondentes ao acréscimo de risco da sua ocorrência em relação à temperatura mínima de mortalidade (TMM) em condições de elevada poluição. Os RRc distritais foram combinados através de uma meta-análise de efeitos aleatórios, considerando a inclusão ou exclusão da versão portuguesa do Índice de Privação Europeu (EDI-PT) como meta-preditor. Resultados: Na maioria dos distritos de Portugal continental observou-se efeito de interação entre calor extremo e poluição elevada por PM na mortalidade, com um RRc que variou entre 1,01 (Intervalo de Confiança a 95% (IC 95%): 0,92; 1,11) e 1,35 (IC 95%: 1,17; 1,56) para o efeito de interação com poluição elevada por PM2,5, e entre 1,01 (IC 95%: 0,86; 1,19) e 1,35 (IC 95%: 1,17; 1,56) para a interação com poluição elevada por PM10, em comparação com o efeito da TMM e poluição elevada. Os efeitos de interação entre calor extremo e poluição elevada (PM2,5 e PM10) em Portugal continental, para temperatura no percentil 90, apresentaram ambos um RRc global de 1,03 (IC 95%: 1,01; 1,05). O EDI-PT não foi incluído na meta-análise por não explicar a heterogeneidade entre distritos. Discussão: Parece existir um efeito sinérgico entre o calor extremo e a poluição elevada por PM na mortalidade em Portugal continental. A integração do conhecimento proveniente destes resultados em medidas de saúde pública poderá contribuir para reforçar os sistemas de vigilância em saúde para melhor monitorizar e responder aos efeitos combinados do calor extremo e da poluição do ar, e mitigar os seus impactos na saúde.
- Implementation of genetic tests for disease prevention: challenges in evidence synthesis across clinical utility domainsPublication . Gris, Angelica Valz; Vicente, Astrid M.; Boccia, StefaniaExcerpt: Robust evidence supports the critical role of genetic risk in shaping the frequency of a broad range of diseases, underscoring its significance as a determinant of health outcomes [1]. Accordingly, genetic and genomic tests hold significant potential for disease prevention by stratifying populations based on individual genetic profiles and guiding targeted interventions. However, despite the enthusiasm surrounding these technologies, their integration into preventive healthcare faces significant hurdles, primarily due to the insufficient evidence supporting their clinical utility [2]. Clinical utility, though not universally defined, generally refers to the test’s usefulness to provide actionable information that improves health outcomes. (...)
- SCCS - Scientific Opinion on Hydroxyapatite (nano) - Submission IVPublication . European Commission. Scientific Committee on Consumer Safety (SCCS)The SCCS concludes the following: (1) In view of the above, and taking into account the scientific data provided, does the SCCS consider Hydroxyapatite (nano) safe when used in toothpaste up to a maximum concentration of 29.5% and in mouthwash up to a maximum concentration of 10% according to the specifications as reported in the submission, taking into account reasonably foreseeable exposure conditions? Based on the data provided, the SCCS considers hydroxyapatite (nano) safe when used at concentrations up to 29.5% in toothpaste, and up to 10% in mouthwash. This conclusion is based on the available evidence, which shows that hydroxyapatite (nano) does not pose a mutagenic hazard or cytotoxicity or inflammatory effects even when tested at high concentrations in a buccal mucosa cell model. Any uptake of hydroxyapatite (nano) by buccal mucosa is considered negligible, and the epithelial cells with internalised particles will be shed out over time as they are continually replaced. Also, any unintentionally ingested HAP nanoparticles during the use of oral-care products will undergo rapid dissolution in the gastric fluid and therefore do not raise any nano-specific concern over safety. This safety evaluation only applies to the hydroxyapatite (nano) that have the following characteristics: - composed of rod-shaped particles of which at least 87% (in particle number) have aspect ratios equal to or less than 3, and the remaining 13% have aspect ratios not exceeding 9. - the HAP particles are not coated or surface modified. - the Opinion is related to HAP particles with max length of the HAP nanoparticles in the present Opinion, i.e. 122 ± 43 nm. 1. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Hydroxyapatite (nano) in cosmetic products? / 2. Does the SCCS have any further scientific concerns with regard to the use of Hydroxyapatite (nano) in oral cosmetic products? This Opinion is not applicable to any hydroxyapatite (nano) material that is composed of or contains needle-shaped particles.