Genotoxicity assessment of chemical mixtures

Simon More, Vasileios Bampidis, Diane Benford, Jos Boesten, Claude Bragard, Thorhallur Halldorsson, Antonio Hernandez‐Jerez, Susanne Hougaard‐Bennekou, Kostas Koutsoumanis, Hanspeter Naegeli, Søren Nielsen, Dieter Schrenk, Vittorio Silano, Dominique Turck, Maged Younes, Gabriele Aquilina, Riccardo Crebelli, Rainer Gürtler, Karen Ildico Hirsch‐Ernst, Pasquale MosessoElsa Ebbesen Nielsen, Roland Solecki, Maria Carfì, Carla Martino, Daniela Maurici, Juan Parra Morte, Josef Schlatter

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Abstract

The EFSA Scientific Committee addressed in this document the peculiarities related to the genotoxicity assessment of chemical mixtures. The EFSA Scientific Committee suggests that first a mixture should be chemically characterised as far as possible. Although the characterisation of mixtures is relevant also for other toxicity aspects, it is particularly significant for the assessment of genotoxicity. If a mixture contains one or more chemical substances that are individually assessed to be genotoxic in vivo via a relevant route of administration, the mixture raises concern for genotoxicity. If a fully chemically defined mixture does not contain genotoxic chemical substances, the mixture is of no concern with respect to genotoxicity. If a mixture contains a fraction of chemical substances that have not been chemically identified, experimental testing of the unidentified fraction should be considered as the first option or, if this is not feasible, testing of the whole mixture should be undertaken. If testing of these fraction(s) or of the whole mixture in an adequately performed set of in vitro assays provides clearly negative results, the mixture does not raise concern for genotoxicity. If in vitro testing provides one or more positive results, an in vivo follow‐up study should be considered. For negative results in the in vivo follow‐up test(s), the possible limitations of in vivo testing should be weighed in an uncertainty analysis before reaching a conclusion of no concern with respect to genotoxicity. For positive results in the in vivo follow‐up test(s), it can be concluded that the mixture does raise a concern about genotoxicity.
Original languageEnglish
Article number5519
JournalEFSA Journal
Volume17
Issue number1
Number of pages11
ISSN1831-4732
DOIs
Publication statusPublished - 2019

Cite this

More, S., Bampidis, V., Benford, D., Boesten, J., Bragard, C., Halldorsson, T., ... Schlatter, J. (2019). Genotoxicity assessment of chemical mixtures. EFSA Journal, 17(1), [5519]. https://doi.org/10.2903/j.efsa.2019.5519
More, Simon ; Bampidis, Vasileios ; Benford, Diane ; Boesten, Jos ; Bragard, Claude ; Halldorsson, Thorhallur ; Hernandez‐Jerez, Antonio ; Hougaard‐Bennekou, Susanne ; Koutsoumanis, Kostas ; Naegeli, Hanspeter ; Nielsen, Søren ; Schrenk, Dieter ; Silano, Vittorio ; Turck, Dominique ; Younes, Maged ; Aquilina, Gabriele ; Crebelli, Riccardo ; Gürtler, Rainer ; Hirsch‐Ernst, Karen Ildico ; Mosesso, Pasquale ; Nielsen, Elsa Ebbesen ; Solecki, Roland ; Carfì, Maria ; Martino, Carla ; Maurici, Daniela ; Parra Morte, Juan ; Schlatter, Josef. / Genotoxicity assessment of chemical mixtures. In: EFSA Journal. 2019 ; Vol. 17, No. 1.
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abstract = "The EFSA Scientific Committee addressed in this document the peculiarities related to the genotoxicity assessment of chemical mixtures. The EFSA Scientific Committee suggests that first a mixture should be chemically characterised as far as possible. Although the characterisation of mixtures is relevant also for other toxicity aspects, it is particularly significant for the assessment of genotoxicity. If a mixture contains one or more chemical substances that are individually assessed to be genotoxic in vivo via a relevant route of administration, the mixture raises concern for genotoxicity. If a fully chemically defined mixture does not contain genotoxic chemical substances, the mixture is of no concern with respect to genotoxicity. If a mixture contains a fraction of chemical substances that have not been chemically identified, experimental testing of the unidentified fraction should be considered as the first option or, if this is not feasible, testing of the whole mixture should be undertaken. If testing of these fraction(s) or of the whole mixture in an adequately performed set of in vitro assays provides clearly negative results, the mixture does not raise concern for genotoxicity. If in vitro testing provides one or more positive results, an in vivo follow‐up study should be considered. For negative results in the in vivo follow‐up test(s), the possible limitations of in vivo testing should be weighed in an uncertainty analysis before reaching a conclusion of no concern with respect to genotoxicity. For positive results in the in vivo follow‐up test(s), it can be concluded that the mixture does raise a concern about genotoxicity.",
author = "Simon More and Vasileios Bampidis and Diane Benford and Jos Boesten and Claude Bragard and Thorhallur Halldorsson and Antonio Hernandez‐Jerez and Susanne Hougaard‐Bennekou and Kostas Koutsoumanis and Hanspeter Naegeli and S{\o}ren Nielsen and Dieter Schrenk and Vittorio Silano and Dominique Turck and Maged Younes and Gabriele Aquilina and Riccardo Crebelli and Rainer G{\"u}rtler and Hirsch‐Ernst, {Karen Ildico} and Pasquale Mosesso and Nielsen, {Elsa Ebbesen} and Roland Solecki and Maria Carf{\`i} and Carla Martino and Daniela Maurici and {Parra Morte}, Juan and Josef Schlatter",
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language = "English",
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More, S, Bampidis, V, Benford, D, Boesten, J, Bragard, C, Halldorsson, T, Hernandez‐Jerez, A, Hougaard‐Bennekou, S, Koutsoumanis, K, Naegeli, H, Nielsen, S, Schrenk, D, Silano, V, Turck, D, Younes, M, Aquilina, G, Crebelli, R, Gürtler, R, Hirsch‐Ernst, KI, Mosesso, P, Nielsen, EE, Solecki, R, Carfì, M, Martino, C, Maurici, D, Parra Morte, J & Schlatter, J 2019, 'Genotoxicity assessment of chemical mixtures', EFSA Journal, vol. 17, no. 1, 5519. https://doi.org/10.2903/j.efsa.2019.5519

Genotoxicity assessment of chemical mixtures. / More, Simon; Bampidis, Vasileios; Benford, Diane; Boesten, Jos; Bragard, Claude; Halldorsson, Thorhallur; Hernandez‐Jerez, Antonio; Hougaard‐Bennekou, Susanne; Koutsoumanis, Kostas; Naegeli, Hanspeter; Nielsen, Søren ; Schrenk, Dieter; Silano, Vittorio; Turck, Dominique; Younes, Maged; Aquilina, Gabriele; Crebelli, Riccardo; Gürtler, Rainer; Hirsch‐Ernst, Karen Ildico; Mosesso, Pasquale; Nielsen, Elsa Ebbesen; Solecki, Roland; Carfì, Maria; Martino, Carla; Maurici, Daniela; Parra Morte, Juan; Schlatter, Josef.

In: EFSA Journal, Vol. 17, No. 1, 5519, 2019.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Genotoxicity assessment of chemical mixtures

AU - More, Simon

AU - Bampidis, Vasileios

AU - Benford, Diane

AU - Boesten, Jos

AU - Bragard, Claude

AU - Halldorsson, Thorhallur

AU - Hernandez‐Jerez, Antonio

AU - Hougaard‐Bennekou, Susanne

AU - Koutsoumanis, Kostas

AU - Naegeli, Hanspeter

AU - Nielsen, Søren

AU - Schrenk, Dieter

AU - Silano, Vittorio

AU - Turck, Dominique

AU - Younes, Maged

AU - Aquilina, Gabriele

AU - Crebelli, Riccardo

AU - Gürtler, Rainer

AU - Hirsch‐Ernst, Karen Ildico

AU - Mosesso, Pasquale

AU - Nielsen, Elsa Ebbesen

AU - Solecki, Roland

AU - Carfì, Maria

AU - Martino, Carla

AU - Maurici, Daniela

AU - Parra Morte, Juan

AU - Schlatter, Josef

PY - 2019

Y1 - 2019

N2 - The EFSA Scientific Committee addressed in this document the peculiarities related to the genotoxicity assessment of chemical mixtures. The EFSA Scientific Committee suggests that first a mixture should be chemically characterised as far as possible. Although the characterisation of mixtures is relevant also for other toxicity aspects, it is particularly significant for the assessment of genotoxicity. If a mixture contains one or more chemical substances that are individually assessed to be genotoxic in vivo via a relevant route of administration, the mixture raises concern for genotoxicity. If a fully chemically defined mixture does not contain genotoxic chemical substances, the mixture is of no concern with respect to genotoxicity. If a mixture contains a fraction of chemical substances that have not been chemically identified, experimental testing of the unidentified fraction should be considered as the first option or, if this is not feasible, testing of the whole mixture should be undertaken. If testing of these fraction(s) or of the whole mixture in an adequately performed set of in vitro assays provides clearly negative results, the mixture does not raise concern for genotoxicity. If in vitro testing provides one or more positive results, an in vivo follow‐up study should be considered. For negative results in the in vivo follow‐up test(s), the possible limitations of in vivo testing should be weighed in an uncertainty analysis before reaching a conclusion of no concern with respect to genotoxicity. For positive results in the in vivo follow‐up test(s), it can be concluded that the mixture does raise a concern about genotoxicity.

AB - The EFSA Scientific Committee addressed in this document the peculiarities related to the genotoxicity assessment of chemical mixtures. The EFSA Scientific Committee suggests that first a mixture should be chemically characterised as far as possible. Although the characterisation of mixtures is relevant also for other toxicity aspects, it is particularly significant for the assessment of genotoxicity. If a mixture contains one or more chemical substances that are individually assessed to be genotoxic in vivo via a relevant route of administration, the mixture raises concern for genotoxicity. If a fully chemically defined mixture does not contain genotoxic chemical substances, the mixture is of no concern with respect to genotoxicity. If a mixture contains a fraction of chemical substances that have not been chemically identified, experimental testing of the unidentified fraction should be considered as the first option or, if this is not feasible, testing of the whole mixture should be undertaken. If testing of these fraction(s) or of the whole mixture in an adequately performed set of in vitro assays provides clearly negative results, the mixture does not raise concern for genotoxicity. If in vitro testing provides one or more positive results, an in vivo follow‐up study should be considered. For negative results in the in vivo follow‐up test(s), the possible limitations of in vivo testing should be weighed in an uncertainty analysis before reaching a conclusion of no concern with respect to genotoxicity. For positive results in the in vivo follow‐up test(s), it can be concluded that the mixture does raise a concern about genotoxicity.

U2 - 10.2903/j.efsa.2019.5519

DO - 10.2903/j.efsa.2019.5519

M3 - Journal article

VL - 17

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 1

M1 - 5519

ER -

More S, Bampidis V, Benford D, Boesten J, Bragard C, Halldorsson T et al. Genotoxicity assessment of chemical mixtures. EFSA Journal. 2019;17(1). 5519. https://doi.org/10.2903/j.efsa.2019.5519