Publikation:

New approach methodologies in human regulatory toxicology : Not if, but how and when!

Lade...
Vorschaubild

Dateien

Schmeisser_2-v44hc2g0w7dp5.pdf
Schmeisser_2-v44hc2g0w7dp5.pdfGröße: 1.58 MBDownloads: 71

Datum

2023

Autor:innen

Schmeisser, Sebastian
Miccoli, Andrea
von Bergen, Martin
Berggren, Elisabet
Braeuning, Albert
Busch, Wibke
Desaintes, Christian
Gourmelon, Anne
et al.

Herausgeber:innen

Kontakt

ISSN der Zeitschrift

Electronic ISSN

ISBN

Bibliografische Daten

Verlag

Schriftenreihe

Auflagebezeichnung

ArXiv-ID

Internationale Patentnummer

Link zur Lizenz

Angaben zur Forschungsförderung

Projekt

Open Access-Veröffentlichung
Open Access Hybrid
Core Facility der Universität Konstanz

Gesperrt bis

Titel in einer weiteren Sprache

Publikationstyp
Zeitschriftenartikel
Publikationsstatus
Published

Erschienen in

Environment International. Elsevier. 2023, 178, 108082. ISSN 0160-4120. eISSN 1873-6750. Available under: doi: 10.1016/j.envint.2023.108082

Zusammenfassung

The predominantly animal-centric approach of chemical safety assessment has increasingly come under pressure. Society is questioning overall performance, sustainability, continued relevance for human health risk assessment and ethics of this system, demanding a change of paradigm. At the same time, the scientific toolbox used for risk assessment is continuously enriched by the development of “New Approach Methodologies” (NAMs). While this term does not define the age or the state of readiness of the innovation, it covers a wide range of methods, including quantitative structure–activity relationship (QSAR) predictions, high-throughput screening (HTS) bioassays, omics applications, cell cultures, organoids, microphysiological systems (MPS), machine learning models and artificial intelligence (AI). In addition to promising faster and more efficient toxicity testing, NAMs have the potential to fundamentally transform today’s regulatory work by allowing more human-relevant decision-making in terms of both hazard and exposure assessment. Yet, several obstacles hamper a broader application of NAMs in current regulatory risk assessment. Constraints in addressing repeated-dose toxicity, with particular reference to the chronic toxicity, and hesitance from relevant stakeholders, are major challenges for the implementation of NAMs in a broader context. Moreover, issues regarding predictivity, reproducibility and quantification need to be addressed and regulatory and legislative frameworks need to be adapted to NAMs. The conceptual perspective presented here has its focus on hazard assessment and is grounded on the main findings and conclusions from a symposium and workshop held in Berlin in November 2021. It intends to provide further insights into how NAMs can be gradually integrated into chemical risk assessment aimed at protection of human health, until eventually the current paradigm is replaced by an animal-free “Next Generation Risk Assessment” (NGRA).

Zusammenfassung in einer weiteren Sprache

Fachgebiet (DDC)
570 Biowissenschaften, Biologie

Schlagwörter

New approach methodologies, Chemical safety, Human health protection, Regulatory risk assessment, Next generation risk assessment, Regulatory toxicology

Konferenz

Rezension
undefined / . - undefined, undefined

Forschungsvorhaben

Organisationseinheiten

Zeitschriftenheft

Zugehörige Datensätze in KOPS

Zitieren

ISO 690SCHMEISSER, Sebastian, Andrea MICCOLI, Martin VON BERGEN, Elisabet BERGGREN, Albert BRAEUNING, Wibke BUSCH, Christian DESAINTES, Anne GOURMELON, Thomas HARTUNG, Marcel LEIST, 2023. New approach methodologies in human regulatory toxicology : Not if, but how and when!. In: Environment International. Elsevier. 2023, 178, 108082. ISSN 0160-4120. eISSN 1873-6750. Available under: doi: 10.1016/j.envint.2023.108082
BibTex
@article{Schmeisser2023-08appro-67537,
  year={2023},
  doi={10.1016/j.envint.2023.108082},
  title={New approach methodologies in human regulatory toxicology : Not if, but how and when!},
  volume={178},
  issn={0160-4120},
  journal={Environment International},
  author={Schmeisser, Sebastian and Miccoli, Andrea and von Bergen, Martin and Berggren, Elisabet and Braeuning, Albert and Busch, Wibke and Desaintes, Christian and Gourmelon, Anne and Hartung, Thomas and Leist, Marcel},
  note={Article Number: 108082}
}
RDF
<rdf:RDF
    xmlns:dcterms="http://purl.org/dc/terms/"
    xmlns:dc="http://purl.org/dc/elements/1.1/"
    xmlns:rdf="http://www.w3.org/1999/02/22-rdf-syntax-ns#"
    xmlns:bibo="http://purl.org/ontology/bibo/"
    xmlns:dspace="http://digital-repositories.org/ontologies/dspace/0.1.0#"
    xmlns:foaf="http://xmlns.com/foaf/0.1/"
    xmlns:void="http://rdfs.org/ns/void#"
    xmlns:xsd="http://www.w3.org/2001/XMLSchema#" > 
  <rdf:Description rdf:about="https://kops.uni-konstanz.de/server/rdf/resource/123456789/67537">
    <dc:contributor>von Bergen, Martin</dc:contributor>
    <dcterms:abstract>The predominantly animal-centric approach of chemical safety assessment has increasingly come under pressure. Society is questioning overall performance, sustainability, continued relevance for human health risk assessment and ethics of this system, demanding a change of paradigm. At the same time, the scientific toolbox used for risk assessment is continuously enriched by the development of “New Approach Methodologies” (NAMs). While this term does not define the age or the state of readiness of the innovation, it covers a wide range of methods, including quantitative structure–activity relationship (QSAR) predictions, high-throughput screening (HTS) bioassays, omics applications, cell cultures, organoids, microphysiological systems (MPS), machine learning models and artificial intelligence (AI). In addition to promising faster and more efficient toxicity testing, NAMs have the potential to fundamentally transform today’s regulatory work by allowing more human-relevant decision-making in terms of both hazard and exposure assessment. Yet, several obstacles hamper a broader application of NAMs in current regulatory risk assessment. Constraints in addressing repeated-dose toxicity, with particular reference to the chronic toxicity, and hesitance from relevant stakeholders, are major challenges for the implementation of NAMs in a broader context. Moreover, issues regarding predictivity, reproducibility and quantification need to be addressed and regulatory and legislative frameworks need to be adapted to NAMs. The conceptual perspective presented here has its focus on hazard assessment and is grounded on the main findings and conclusions from a symposium and workshop held in Berlin in November 2021. It intends to provide further insights into how NAMs can be gradually integrated into chemical risk assessment aimed at protection of human health, until eventually the current paradigm is replaced by an animal-free “Next Generation Risk Assessment” (NGRA).</dcterms:abstract>
    <dspace:isPartOfCollection rdf:resource="https://kops.uni-konstanz.de/server/rdf/resource/123456789/28"/>
    <dc:contributor>Miccoli, Andrea</dc:contributor>
    <dc:contributor>Braeuning, Albert</dc:contributor>
    <dc:contributor>Leist, Marcel</dc:contributor>
    <dc:creator>Leist, Marcel</dc:creator>
    <dc:contributor>Busch, Wibke</dc:contributor>
    <dc:creator>von Bergen, Martin</dc:creator>
    <dc:rights>Attribution 4.0 International</dc:rights>
    <dc:creator>Desaintes, Christian</dc:creator>
    <foaf:homepage rdf:resource="http://localhost:8080/"/>
    <dc:creator>Hartung, Thomas</dc:creator>
    <void:sparqlEndpoint rdf:resource="http://localhost/fuseki/dspace/sparql"/>
    <dcterms:isPartOf rdf:resource="https://kops.uni-konstanz.de/server/rdf/resource/123456789/28"/>
    <dc:contributor>Schmeisser, Sebastian</dc:contributor>
    <dc:creator>Berggren, Elisabet</dc:creator>
    <dc:creator>Schmeisser, Sebastian</dc:creator>
    <dc:creator>Busch, Wibke</dc:creator>
    <bibo:uri rdf:resource="https://kops.uni-konstanz.de/handle/123456789/67537"/>
    <dcterms:rights rdf:resource="http://creativecommons.org/licenses/by/4.0/"/>
    <dc:contributor>Berggren, Elisabet</dc:contributor>
    <dcterms:available rdf:datatype="http://www.w3.org/2001/XMLSchema#dateTime">2023-08-08T14:16:40Z</dcterms:available>
    <dcterms:issued>2023-08</dcterms:issued>
    <dcterms:title>New approach methodologies in human regulatory toxicology : Not if, but how and when!</dcterms:title>
    <dc:creator>Braeuning, Albert</dc:creator>
    <dc:creator>Gourmelon, Anne</dc:creator>
    <dc:creator>Miccoli, Andrea</dc:creator>
    <dc:contributor>Desaintes, Christian</dc:contributor>
    <dc:contributor>Gourmelon, Anne</dc:contributor>
    <dc:contributor>Hartung, Thomas</dc:contributor>
    <dc:date rdf:datatype="http://www.w3.org/2001/XMLSchema#dateTime">2023-08-08T14:16:40Z</dc:date>
    <dspace:hasBitstream rdf:resource="https://kops.uni-konstanz.de/bitstream/123456789/67537/1/Schmeisser_2-v44hc2g0w7dp5.pdf"/>
    <dc:language>eng</dc:language>
    <dcterms:hasPart rdf:resource="https://kops.uni-konstanz.de/bitstream/123456789/67537/1/Schmeisser_2-v44hc2g0w7dp5.pdf"/>
  </rdf:Description>
</rdf:RDF>

Interner Vermerk

xmlui.Submission.submit.DescribeStep.inputForms.label.kops_note_fromSubmitter

Kontakt
URL der Originalveröffentl.

Prüfdatum der URL

Prüfungsdatum der Dissertation

Finanzierungsart

Kommentar zur Publikation

Allianzlizenz
Corresponding Authors der Uni Konstanz vorhanden
Internationale Co-Autor:innen
Universitätsbibliographie
Ja
Begutachtet
Ja
Diese Publikation teilen