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 Saxmose

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

AU - Solecki, Roland

AU - Carfì, Maria

AU - Martino, Carla

AU - Maurici, Daniela

AU - Parra Morte, Juan

AU - Schlatter, Josef

PY - 2019/1/1

Y1 - 2019/1/1

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.

KW - genotoxicity assessment

KW - chemical mixtures

KW - uncertainty analysis

U2 - 10.2903/j.efsa.2019.5519

DO - 10.2903/j.efsa.2019.5519

M3 - Journal article

C2 - 32626066

VL - 17

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 1

M1 - e05519

ER -