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Genotoxicity assessment of chemical mixtures

Author(s)
More, Simon John  
Bampidis, Vasileios  
Benford, Diane  
et al.  
Uri
http://hdl.handle.net/10197/9918
Date Issued
2019-01-17
Date Available
2019-04-11T11:07:45Z
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.
Type of Material
Journal Article
Publisher
Wiley
Journal
EFSA Journal
Volume
17
Issue
1
Start Page
1
End Page
11
Copyright (Published Version)
2019 European Food Safety Authority
Subjects

Genotoxicity assessme...

Chemical mixtures

Uncertainty analysis

DOI
10.2903/j.efsa.2019.5519
Language
English
Status of Item
Peer reviewed
ISSN
1831-4732
This item is made available under a Creative Commons License
https://creativecommons.org/licenses/by-nc-nd/3.0/ie/
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Committee_et_al-2019-EFSA_Journal.pdf

Size

1.17 MB

Format

Adobe PDF

Checksum (MD5)

c2fba57f0d4644c8fbe7a3d16a7a4d13

Owning collection
Veterinary Medicine Research Collection
Mapped collections
CVERA Research Collection

Item descriptive metadata is released under a CC-0 (public domain) license: https://creativecommons.org/public-domain/cc0/.
All other content is subject to copyright.

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