Consensus statement on the need for innovation, transition and implementation of developmental neurotoxicity (DNT) testing for regulatory purposes

Ellen Fritsche, Philippe Grandjean, Kevin M Crofton, Michael Aschner, Alan Goldberg, Tuula Heinonen, Ellen V S Hessel, Helena T Hogberg, Susanne Hougaard Bennekou, Pamela J Lein, Marcel Leist, William R Mundy, Martin Paparella, Aldert H Piersma, Magdalini Sachana, Gabriele Schmuck, Roland Solecki, Andrea Terron, Florianne Monnet-Tschudi, Martin F Wilks & 3 andre Hilda Witters, Marie-Gabrielle Zurich, Anna Bal-Price

Publikation: Bidrag til tidsskriftKommentar/debatForskningpeer review

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Resumé

This consensus statement voices the agreement of scientific stakeholders from regulatory agencies, academia and industry that a new framework needs adopting for assessment of chemicals with the potential to disrupt brain development. An increased prevalence of neurodevelopmental disorders in children has been observed that cannot solely be explained by genetics and recently pre- and postnatal exposure to environmental chemicals has been suspected as a causal factor. There is only very limited information on neurodevelopmental toxicity, leaving thousands of chemicals, that are present in the environment, with high uncertainty concerning their developmental neurotoxicity (DNT) potential. Closing this data gap with the current test guideline approach is not feasible, because the in vivo bioassays are far too resource-intensive concerning time, money and number of animals. A variety of in vitro methods are now available, that have the potential to close this data gap by permitting mode-of-action-based DNT testing employing human stem cells-derived neuronal/glial models. In vitro DNT data together with in silico approaches will in the future allow development of predictive models for DNT effects. The ultimate application goals of these new approach methods for DNT testing are their usage for different regulatory purposes.

OriginalsprogEngelsk
TidsskriftToxicology and Applied Pharmacology
Vol/bind354
Sider (fra-til)3-6
ISSN0041-008X
DOI
StatusUdgivet - sep. 2018

Fingeraftryk

Consensus
Innovation
Needs Assessment
Environmental Exposure
Testing
Neuroglia
Computer Simulation
Uncertainty
Bioassay
Guidelines
Stem cells
Toxicity
Brain
Animals
In Vitro Techniques
Industry
Genetics

Citer dette

Fritsche, Ellen ; Grandjean, Philippe ; Crofton, Kevin M ; Aschner, Michael ; Goldberg, Alan ; Heinonen, Tuula ; Hessel, Ellen V S ; Hogberg, Helena T ; Bennekou, Susanne Hougaard ; Lein, Pamela J ; Leist, Marcel ; Mundy, William R ; Paparella, Martin ; Piersma, Aldert H ; Sachana, Magdalini ; Schmuck, Gabriele ; Solecki, Roland ; Terron, Andrea ; Monnet-Tschudi, Florianne ; Wilks, Martin F ; Witters, Hilda ; Zurich, Marie-Gabrielle ; Bal-Price, Anna. / Consensus statement on the need for innovation, transition and implementation of developmental neurotoxicity (DNT) testing for regulatory purposes. I: Toxicology and Applied Pharmacology. 2018 ; Bind 354. s. 3-6.
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title = "Consensus statement on the need for innovation, transition and implementation of developmental neurotoxicity (DNT) testing for regulatory purposes",
abstract = "This consensus statement voices the agreement of scientific stakeholders from regulatory agencies, academia and industry that a new framework needs adopting for assessment of chemicals with the potential to disrupt brain development. An increased prevalence of neurodevelopmental disorders in children has been observed that cannot solely be explained by genetics and recently pre- and postnatal exposure to environmental chemicals has been suspected as a causal factor. There is only very limited information on neurodevelopmental toxicity, leaving thousands of chemicals, that are present in the environment, with high uncertainty concerning their developmental neurotoxicity (DNT) potential. Closing this data gap with the current test guideline approach is not feasible, because the in vivo bioassays are far too resource-intensive concerning time, money and number of animals. A variety of in vitro methods are now available, that have the potential to close this data gap by permitting mode-of-action-based DNT testing employing human stem cells-derived neuronal/glial models. In vitro DNT data together with in silico approaches will in the future allow development of predictive models for DNT effects. The ultimate application goals of these new approach methods for DNT testing are their usage for different regulatory purposes.",
keywords = "Journal Article, In vitro testing, Developmental neurotoxicity, Regulatory purposes, Reproducibility of Results, Age Factors, Risk Assessment, Humans, Neurons/drug effects, Toxicity Tests/methods, Neurotoxicity Syndromes/etiology, Consensus, Animal Testing Alternatives/standards, Stakeholder Participation, Brain/drug effects, Animals, Toxicology/methods, Policy Making, Diffusion of Innovation",
author = "Ellen Fritsche and Philippe Grandjean and Crofton, {Kevin M} and Michael Aschner and Alan Goldberg and Tuula Heinonen and Hessel, {Ellen V S} and Hogberg, {Helena T} and Bennekou, {Susanne Hougaard} and Lein, {Pamela J} and Marcel Leist and Mundy, {William R} and Martin Paparella and Piersma, {Aldert H} and Magdalini Sachana and Gabriele Schmuck and Roland Solecki and Andrea Terron and Florianne Monnet-Tschudi and Wilks, {Martin F} and Hilda Witters and Marie-Gabrielle Zurich and Anna Bal-Price",
note = "Copyright {\circledC} 2018 The Authors. Published by Elsevier Inc. All rights reserved.",
year = "2018",
month = "9",
doi = "10.1016/j.taap.2018.02.004",
language = "English",
volume = "354",
pages = "3--6",
journal = "Toxicology and Applied Pharmacology",
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Fritsche, E, Grandjean, P, Crofton, KM, Aschner, M, Goldberg, A, Heinonen, T, Hessel, EVS, Hogberg, HT, Bennekou, SH, Lein, PJ, Leist, M, Mundy, WR, Paparella, M, Piersma, AH, Sachana, M, Schmuck, G, Solecki, R, Terron, A, Monnet-Tschudi, F, Wilks, MF, Witters, H, Zurich, M-G & Bal-Price, A 2018, 'Consensus statement on the need for innovation, transition and implementation of developmental neurotoxicity (DNT) testing for regulatory purposes', Toxicology and Applied Pharmacology, bind 354, s. 3-6. https://doi.org/10.1016/j.taap.2018.02.004

Consensus statement on the need for innovation, transition and implementation of developmental neurotoxicity (DNT) testing for regulatory purposes. / Fritsche, Ellen; Grandjean, Philippe; Crofton, Kevin M; Aschner, Michael; Goldberg, Alan; Heinonen, Tuula; Hessel, Ellen V S; Hogberg, Helena T; Bennekou, Susanne Hougaard; Lein, Pamela J; Leist, Marcel; Mundy, William R; Paparella, Martin; Piersma, Aldert H; Sachana, Magdalini; Schmuck, Gabriele; Solecki, Roland; Terron, Andrea; Monnet-Tschudi, Florianne; Wilks, Martin F; Witters, Hilda; Zurich, Marie-Gabrielle; Bal-Price, Anna.

I: Toxicology and Applied Pharmacology, Bind 354, 09.2018, s. 3-6.

Publikation: Bidrag til tidsskriftKommentar/debatForskningpeer review

TY - JOUR

T1 - Consensus statement on the need for innovation, transition and implementation of developmental neurotoxicity (DNT) testing for regulatory purposes

AU - Fritsche, Ellen

AU - Grandjean, Philippe

AU - Crofton, Kevin M

AU - Aschner, Michael

AU - Goldberg, Alan

AU - Heinonen, Tuula

AU - Hessel, Ellen V S

AU - Hogberg, Helena T

AU - Bennekou, Susanne Hougaard

AU - Lein, Pamela J

AU - Leist, Marcel

AU - Mundy, William R

AU - Paparella, Martin

AU - Piersma, Aldert H

AU - Sachana, Magdalini

AU - Schmuck, Gabriele

AU - Solecki, Roland

AU - Terron, Andrea

AU - Monnet-Tschudi, Florianne

AU - Wilks, Martin F

AU - Witters, Hilda

AU - Zurich, Marie-Gabrielle

AU - Bal-Price, Anna

N1 - Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

PY - 2018/9

Y1 - 2018/9

N2 - This consensus statement voices the agreement of scientific stakeholders from regulatory agencies, academia and industry that a new framework needs adopting for assessment of chemicals with the potential to disrupt brain development. An increased prevalence of neurodevelopmental disorders in children has been observed that cannot solely be explained by genetics and recently pre- and postnatal exposure to environmental chemicals has been suspected as a causal factor. There is only very limited information on neurodevelopmental toxicity, leaving thousands of chemicals, that are present in the environment, with high uncertainty concerning their developmental neurotoxicity (DNT) potential. Closing this data gap with the current test guideline approach is not feasible, because the in vivo bioassays are far too resource-intensive concerning time, money and number of animals. A variety of in vitro methods are now available, that have the potential to close this data gap by permitting mode-of-action-based DNT testing employing human stem cells-derived neuronal/glial models. In vitro DNT data together with in silico approaches will in the future allow development of predictive models for DNT effects. The ultimate application goals of these new approach methods for DNT testing are their usage for different regulatory purposes.

AB - This consensus statement voices the agreement of scientific stakeholders from regulatory agencies, academia and industry that a new framework needs adopting for assessment of chemicals with the potential to disrupt brain development. An increased prevalence of neurodevelopmental disorders in children has been observed that cannot solely be explained by genetics and recently pre- and postnatal exposure to environmental chemicals has been suspected as a causal factor. There is only very limited information on neurodevelopmental toxicity, leaving thousands of chemicals, that are present in the environment, with high uncertainty concerning their developmental neurotoxicity (DNT) potential. Closing this data gap with the current test guideline approach is not feasible, because the in vivo bioassays are far too resource-intensive concerning time, money and number of animals. A variety of in vitro methods are now available, that have the potential to close this data gap by permitting mode-of-action-based DNT testing employing human stem cells-derived neuronal/glial models. In vitro DNT data together with in silico approaches will in the future allow development of predictive models for DNT effects. The ultimate application goals of these new approach methods for DNT testing are their usage for different regulatory purposes.

KW - Journal Article

KW - In vitro testing

KW - Developmental neurotoxicity

KW - Regulatory purposes

KW - Reproducibility of Results

KW - Age Factors

KW - Risk Assessment

KW - Humans

KW - Neurons/drug effects

KW - Toxicity Tests/methods

KW - Neurotoxicity Syndromes/etiology

KW - Consensus

KW - Animal Testing Alternatives/standards

KW - Stakeholder Participation

KW - Brain/drug effects

KW - Animals

KW - Toxicology/methods

KW - Policy Making

KW - Diffusion of Innovation

U2 - 10.1016/j.taap.2018.02.004

DO - 10.1016/j.taap.2018.02.004

M3 - Comment/debate

VL - 354

SP - 3

EP - 6

JO - Toxicology and Applied Pharmacology

JF - Toxicology and Applied Pharmacology

SN - 0041-008X

ER -