Guidance on aneugenicity assessment

Files in This Item:
 File SizeFormat
Downloadj.efsa.2021.6770.pdf2.84 MBAdobe PDF
Title: Guidance on aneugenicity assessment
Authors: European Food Safety Authority (EFSA), Scientific CommitteeMore, Simon JohnBampidis, VasileiosBragard, Claudeet al.
Permanent link:
Date: Aug-2021
Online since: 2022-08-19T14:16:43Z
Abstract: 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.
Type of material: Journal Article
Publisher: Wiley
Journal: EFSA Journal
Volume: 19
Issue: 8
Copyright (published version): 2021 European Food Safety Authority
Keywords: AneugenicityMicronucleus testGenotoxicityIn vivoIn vitro
DOI: 10.2903/j.efsa.2021.6770
Language: en
Status of Item: Peer reviewed
ISSN: 1831-4732
This item is made available under a Creative Commons License:
Appears in Collections:Veterinary Medicine Research Collection
CVERA Research Collection

Show full item record

Page view(s)

Last Week
Last month
checked on Oct 5, 2022


checked on Oct 5, 2022

Google ScholarTM



If you are a publisher or author and have copyright concerns for any item, please email and the item will be withdrawn immediately. The author or person responsible for depositing the article will be contacted within one business day.