Title :

Guidance on aneugenicity assessment.

Author(s) :

More, S. J. [Auteur]
European Food Safety Authority [EFSA]
Bampidis, V. [Auteur]
Bragard, C. [Auteur]
Halldorsson, T. I. [Auteur]
Hernández-Jerez, A. F. [Auteur]
Hougaard Bennekou, S. [Auteur]
Koutsoumanis, K. [Auteur]
Lambré, C. [Auteur]
Machera, K. [Auteur]
Naegeli, H. [Auteur]
Nielsen, S. S. [Auteur]
Schlatter, J. [Auteur]
Schrenk, D. [Auteur]
Turck, Dominique [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Younes, M. [Auteur]
Aquilina, G. [Auteur]
Bignami, M. [Auteur]
Bolognesi, C. [Auteur]
Crebelli, R. [Auteur]
Gürtler, R. [Auteur]
Marcon, F. [Auteur]
Nielsen, E. [Auteur]
Vleminckx, C. [Auteur]
Carfì, M. [Auteur]
Martino, C. [Auteur]
Maurici, D. [Auteur]
Parra Morte, J. [Auteur]
Rossi, A. [Auteur]
Benford, D. [Auteur]

Journal title :

EFSA Journal

Abbreviated title :

EFSA J

Volume number :

19

Pages :

e06770

Publication date :

2021-08-17

ISSN :

1831-4732

English keyword(s) :

aneugenicity
micronucleus test
genotoxicity in vivo and in vitro

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

The EFSA Scientific Committee was asked to provide guidance on the most appropriatein vivotests tofollow up on positivein vitroresults for aneugenicity, and on the approach to risk assessment forsubstances that are ...
Show more >The EFSA Scientific Committee was asked to provide guidance on the most appropriatein vivotests tofollow up on positivein vitroresults for aneugenicity, and on the approach to risk assessment forsubstances that are aneugenic but not clastogenic nor causing gene mutations. The ScientificCommittee confirmed that the preferred approach is to perform anin vivomammalian erythrocytemicronucleus test with a relevant route of administration. If this is positive, it demonstrates that thesubstance is aneugenicin vivo. A negative result with evidence that the bone marrow is exposed tothe test substance supports a conclusion that aneugenic activity is not expressedin vivo. If there is noevidence of exposure to the bone marrow, a negative result is viewed as inconclusive and furtherstudies are required. The liver micronucleus assay, even though not yet fully validated, can providesupporting information for substances that are aneugenic following metabolic activation. Thegastrointestinal micronucleus test, conversely, to be further developed, may help to assess aneugenicpotential at the initial site of contact for substances that are aneugenicin vitrowithout metabolicactivation. Based on the evidence in relation to mechanisms of aneugenicity, the Scientific Committeeconcluded that, in principle, health-based guidance values can be established for substances that areaneugenic but not clastogenic nor causing gene mutations, provided that a comprehensivetoxicological database is available. For situations in which the toxicological database is not sufficient toestablish health-based guidance values, some approaches to risk assessment are proposed. TheScientific Committee recommends further development of the gastrointestinal micronucleus test, andresearch to improve the understanding of aneugenicity to support risk assessment.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Submission date :

2024-01-12T06:14:02Z
2024-03-01T11:24:54Z