Scientific Opinion on Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3): Consideration of genotoxic potential for α,β‐unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 of FGE.19
Autor: | Agneta Oskarsson, Karl-Heinz Engel, Rainer Gürtler, Laurence Castle, Gabriele Aquilina, Flavourings (Faf), Gisela H. Degen, Kevin Chipman, Maria Carfì, Giorgia Vianello, Peter Moldeus, Eugenia Cordelli, Romualdo Benigni, Ursula Gundert-Remy, Romina Shah, Trine Husøy, Wim Mennes, Maria Jose Frutos Fernandez, Paul Fowler, Ine Waalkens-Berendsen, Peter Fürst, Maged Younes, Daniel Marzin, Camilla Svendsen, Detlef Wölfle, Claudia Bolognesi |
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Rok vydání: | 2019 |
Předmět: |
α
β‐unsaturated alicyclic ketones food.ingredient 040301 veterinary sciences DNA damage Veterinary (miscellaneous) Group evaluation TP1-1185 Plant Science 010501 environmental sciences Pharmacology medicine.disease_cause 01 natural sciences Microbiology FGE.210 0403 veterinary science Alicyclic compound food medicine TX341-641 0105 earth and related environmental sciences chemistry.chemical_classification Nutrition. Foods and food supply Chemical technology subgroup 2.4 Food additive FGE.19 safety evaluation 04 agricultural and veterinary sciences flavouring substances Comet assay Scientific Opinion chemistry Micronucleus test Animal Science and Zoology Parasitology Micronucleus Genotoxicity Food Science |
Zdroj: | EFSA Journal EFSA Journal, Vol 17, Iss 5, Pp n/a-n/a (2019) |
ISSN: | 1831-4732 |
Popis: | The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 5 flavouring substances in Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3). In FGE.210, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the genotoxic potential could not be ruled out for any of the flavouring substances. In FGE.210Rev1, the concern for genotoxic potential has been ruled out for eight substances [FL‐no: 02.105, 07.007, 07.009, 07.011, 07.036, 07.088, 07.091 and 07.170]. In FGE.210 Rev2, the concern for genotoxic potential has been ruled out for allyl α‐ionone [FL‐no: 07.061]. In the present revision of FGE 210 (FGE.210Rev3), additional in vitro and in vivo data on the representative substance α‐damascone [FL‐no: 07.134] are evaluated. To investigate equivocal and positive results observed in in vitro micronucleus studies, an in vivo combined micronucleus (bone marrow) and comet assay (liver and duodenum) was performed. α‐Damascone did not induce micronuclei in bone marrow and no primary DNA damage in duodenum; however, an increase in primary DNA damage was observed in liver. This positive result was attributed by the applicant to a high level of peroxides in the sample tested. Therefore, the comet assay was repeated with a new sample of α‐damascone, confirming the negative results observed in duodenum, but equivocal results were observed in liver. Two additional in vivo comet assays in liver were performed in order to clarify the potential impact of peroxides on the obtained results from the genotoxicity testing. However, the materials studied in these tests were not suitable to establish the potential role of peroxides in the genotoxicity of α‐damascone. The Panel concluded that the concern for genotoxicity cannot be ruled out for α‐damascone [FL‐no: 07.134] and the four structurally related substances [FL‐no: 07.130, 07.225, 07.226 and 07.231]. |
Databáze: | OpenAIRE |
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