RT Journal Article
T1 Guidance on aneugenicity assessment.
A1 EFSA Scientific Committee (SC), 
A1 More, Simon John
A1 Bampidis, Vasileios
A1 Bragard, Claude
A1 Halldorsson, Thorhallur Ingi
A1 Hernández-Jerez, Antonio F
A1 Hougaard Bennekou, Susanne
A1 Koutsoumanis, Kostas
A1 Lambré, Claude
A1 Machera, Kyriaki
A1 Naegeli, Hanspeter
A1 Nielsen, Søren Saxmose
A1 Schlatter, Josef
A1 Schrenk, Dieter
A1 Turck, Dominique
A1 Younes, Maged
A1 Aquilina, Gabriele
A1 Bignami, Margherita
A1 Bolognesi, Claudia
A1 Crebelli, Riccardo
A1 Gürtler, Rainer
A1 Marcon, Francesca
A1 Nielsen, Elsa
A1 Vleminckx, Christiane
A1 Carfì, Maria
A1 Martino, Carla
A1 Maurici, Daniela
A1 Parra Morte, Juan
A1 Rossi, Annamaria
A1 Benford, Diane
K1 aneugenicity
K1 genotoxicity in vivo and in vitro
K1 micronucleus test
AB The EFSA Scientific Committee was asked to provide guidance on the most appropriate in vivo tests to follow up on positive in vitro results for aneugenicity, and on the approach to risk assessment for substances that are aneugenic but not clastogenic nor causing gene mutations. The Scientific Committee confirmed that the preferred approach is to perform an in vivo mammalian erythrocyte micronucleus test with a relevant route of administration. If this is positive, it demonstrates that the substance is aneugenic in vivo. A negative result with evidence that the bone marrow is exposed to the test substance supports a conclusion that aneugenic activity is not expressed in vivo. If there is no evidence of exposure to the bone marrow, a negative result is viewed as inconclusive and further studies are required. The liver micronucleus assay, even though not yet fully validated, can provide supporting information for substances that are aneugenic following metabolic activation. The gastrointestinal micronucleus test, conversely, to be further developed, may help to assess aneugenic potential at the initial site of contact for substances that are aneugenic in vitro without metabolic activation. Based on the evidence in relation to mechanisms of aneugenicity, the Scientific Committee concluded that, in principle, health-based guidance values can be established for substances that are aneugenic but not clastogenic nor causing gene mutations, provided that a comprehensive toxicological database is available. For situations in which the toxicological database is not sufficient to establish health-based guidance values, some approaches to risk assessment are proposed. The Scientific Committee recommends further development of the gastrointestinal micronucleus test, and research to improve the understanding of aneugenicity to support risk assessment.
YR 2021
FD 2021-08-05
LK https://hdl.handle.net/10668/26742
UL https://hdl.handle.net/10668/26742
LA en
DS RISalud
RD Apr 10, 2025