Scientific Opinion on Flavouring Group Evaluation 205 (FGE.205):Consideration of genotoxicity data on representatives for 13 α,β-unsaturated aliphatic ketones with terminal double bonds and precursors from chemical subgroup 1.2.2 of FGE.19 by EFSA
2012
EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)
<p>The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider in the Flavouring Group Evaluation 205, the additional data on genotoxicity submitted by the Industry on two representative substances, oct-1-en-3-one [FL-no: 07.081] and pent-1-en-3-one [FL-no: 07.102], from subgroup 1.2.2 of FGE.19. The Panel concluded that both substances were weakly genotoxic in bacteria with pent-1-en-3-one being the most potent (previously available data). In these assays the representative substances were highly cytotoxic with a steep toxicity curve, and with a very narrow concentration range resulting in mutagenicity. Both substances were also tested in mammalian cells for gene mutations at the hprt locus and for structural and numerical chromosomal aberrations in the micronucleus assay. Also in mammalian cells the test substances were highly cytotoxic. The Panel considered that the positive effects in the bacterial mutagenicity assays of the two representative substances cannot be overruled by the one negative and one equivocal gene mutation test in mammalian cells and the Panel recommend that an in vivo Comet assay on the first site of contact (e.g. the stomach) and on the liver is requested on the most potent of the representative substances, pent-1-en-3-one.</p>
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