The document discusses the EU-ToxRisk project which aims to move toxicological assessment away from animal models towards human cell-based in vitro tests and better understanding of chemical adverse effects. It summarizes the EU-ToxRisk read-across strategy for filling data gaps, which involves characterizing target compounds, identifying similar source compounds, evaluating the source compounds, assessing uncertainties, and deriving no-observed adverse effect levels and derived no-effect levels. Main reasons for rejection of read-across justifications include unclear substance identity, lack of evidence supporting assumptions, inappropriate source data selection, and lack of scientific plausibility.
Some slides are in Italian
Summary and description of the principle of investigative toxicology, that is the use of in vitro methods and microphysiological systems for a better prediction of the effect of a drug into the huamn organism
QIVIVE extrapolation requires a precise correlation between exposure and the effective chemical concentration at the site where the MIE occurs.
This work demonstrates that intracellular distribution is not ruled only by physical-chemical parameters, rather it is mainly regulated by specific biological-mediated mechanisms. Substances with
apparent chemical similarity may show different distribution profile, as shown by the intra-nuclear distribution of polyphenols. While our results derive from a limited number of substances applied to
one cell line, it is plausible that using different substances and/or different cell lines would also have shown that intracellular distribution is not directly related to physical-chemical parameters.
Chemical uptake should be specifically measured and simple extrapolations based on physical-chemical properties may provide misleading decision
The document discusses the EU-ToxRisk project which aims to move toxicological assessment away from animal models towards human cell-based in vitro tests and better understanding of chemical adverse effects. It summarizes the EU-ToxRisk read-across strategy for filling data gaps, which involves characterizing target compounds, identifying similar source compounds, evaluating the source compounds, assessing uncertainties, and deriving no-observed adverse effect levels and derived no-effect levels. Main reasons for rejection of read-across justifications include unclear substance identity, lack of evidence supporting assumptions, inappropriate source data selection, and lack of scientific plausibility.
Some slides are in Italian
Summary and description of the principle of investigative toxicology, that is the use of in vitro methods and microphysiological systems for a better prediction of the effect of a drug into the huamn organism
QIVIVE extrapolation requires a precise correlation between exposure and the effective chemical concentration at the site where the MIE occurs.
This work demonstrates that intracellular distribution is not ruled only by physical-chemical parameters, rather it is mainly regulated by specific biological-mediated mechanisms. Substances with
apparent chemical similarity may show different distribution profile, as shown by the intra-nuclear distribution of polyphenols. While our results derive from a limited number of substances applied to
one cell line, it is plausible that using different substances and/or different cell lines would also have shown that intracellular distribution is not directly related to physical-chemical parameters.
Chemical uptake should be specifically measured and simple extrapolations based on physical-chemical properties may provide misleading decision
7. costanza rovida in vitro development of alternative testing from monolayer...crovida
This document summarizes a presentation on in vitro alternative methods to animal testing for evaluating endocrine disruptors. It discusses the use of 3D organoid cultures that better model tissue complexity compared to traditional monolayer cultures. A conceptual framework is presented that outlines a tiered approach moving from in vitro assays to more comprehensive in vivo assays. Opportunities for 3D cultures to improve reproducibility and endpoints are mentioned. Developing human "mini brains" from induced pluripotent stem cells is highlighted as a promising approach for studying gene-environment interactions.
This document discusses New Approach Methodologies (NAM) for biomedical research as alternatives to traditional animal testing. It provides background on the 3Rs principle of replacing, reducing, and refining animal use. It then describes several NAMs including induced pluripotent stem cells, organ-on-chip models, disease-in-a-dish models using human tissues, increased use of biomarkers and 'omics technologies, and in silico methods like computational modeling. The document argues these methods can help map chemical toxicity more efficiently while also allowing studies of individual human variability, disease modeling, and multi-organ interactions in ways not possible with animal models. It concludes by providing additional resources for learning more about alternative methods.
Testing strategy for the assessment of skin and eye irritation potential of chemicals, mainly in the scope of REACH.
The presentation is partially in Italian
Endocrine disruptors as they are regulated in the EUcrovida
The document discusses the regulation of chemicals and implementation of regulatory issues related to endocrine disruptors. It provides an overview of EU regulations for chemicals, plant protection products, and biocidal products, outlining criteria for identifying and restricting endocrine disrupting substances. A history of the endocrine disruptor concept is given from early studies in the 1930s and 1940s to more recent regulatory definitions and screening methods. Candidate substances of concern are listed from ECHA databases. Adaptation of data requirements is discussed, noting confirmation of in vitro screening results through in vivo testing may be waived in some cases.
EU REACH regulation changed the way to do chemical risk assessment. All chemicals marketed or manufactured in the EU must have its own dossier. Non standard methods including alternatives to animal testing are accepted.
Half Italian, half English
7. costanza rovida in vitro development of alternative testing from monolayer...crovida
This document summarizes a presentation on in vitro alternative methods to animal testing for evaluating endocrine disruptors. It discusses the use of 3D organoid cultures that better model tissue complexity compared to traditional monolayer cultures. A conceptual framework is presented that outlines a tiered approach moving from in vitro assays to more comprehensive in vivo assays. Opportunities for 3D cultures to improve reproducibility and endpoints are mentioned. Developing human "mini brains" from induced pluripotent stem cells is highlighted as a promising approach for studying gene-environment interactions.
This document discusses New Approach Methodologies (NAM) for biomedical research as alternatives to traditional animal testing. It provides background on the 3Rs principle of replacing, reducing, and refining animal use. It then describes several NAMs including induced pluripotent stem cells, organ-on-chip models, disease-in-a-dish models using human tissues, increased use of biomarkers and 'omics technologies, and in silico methods like computational modeling. The document argues these methods can help map chemical toxicity more efficiently while also allowing studies of individual human variability, disease modeling, and multi-organ interactions in ways not possible with animal models. It concludes by providing additional resources for learning more about alternative methods.
Testing strategy for the assessment of skin and eye irritation potential of chemicals, mainly in the scope of REACH.
The presentation is partially in Italian
Endocrine disruptors as they are regulated in the EUcrovida
The document discusses the regulation of chemicals and implementation of regulatory issues related to endocrine disruptors. It provides an overview of EU regulations for chemicals, plant protection products, and biocidal products, outlining criteria for identifying and restricting endocrine disrupting substances. A history of the endocrine disruptor concept is given from early studies in the 1930s and 1940s to more recent regulatory definitions and screening methods. Candidate substances of concern are listed from ECHA databases. Adaptation of data requirements is discussed, noting confirmation of in vitro screening results through in vivo testing may be waived in some cases.
EU REACH regulation changed the way to do chemical risk assessment. All chemicals marketed or manufactured in the EU must have its own dossier. Non standard methods including alternatives to animal testing are accepted.
Half Italian, half English
8. • Article category
• Produzione nella UE?
✓ si
✓ no
✓ preferisco non dirlo
• Figura (allegare foto)
• Altezza, larghezza, lunghezza, diametro
• Densità
• Peso, volume
• Colore
• Altre caratteristiche
• Istruzioni per un uso sicuro
• Istruzioni per la separazione (Disassembling instruction)
Dati generali da inserire
9. Article Category
Composta da:
CN, Combined Nomenclature + Descrizione
Allegato I del Regolamento (CEE) n. 2658/87 (guardare aggiornamenti)
Esempio:
Sezione VII
Materie plastiche e lavori di tali materie; gomma e lavori di gomma
39. Materie plastiche e lavori di tali materie
3904: Polymers of vinyl chloride or of other halogenated olefins,
in primary forms
3904 2100 90: Other
In IUCLID 6, sarà presente una selezione da un menù a tendina
Opzioni generiche sono sempre disponibili
23. Riassunto
1. Accedo a IUCLID 6
2. Creo l’oggetto che contiene una sostanza SVHC
3. Creo l’oggetto complesso che lo contiene
4. Verifico con la funzione «validate» che non ci siano errori
5. Creo il dossier
6. Invio il dossier a ECHA
Grazie per l’attenzione!