2,5-DIMETHYL-3-ACETYLFURAN

Meeting:

86

Specs Code:

M

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Comments:

The Committee concluded that the Procedure could not be applied to this group because of unresolved toxicological concerns. Studies that could assist in the safety evaluation include investigations of the influence of the nature and position of furan ring substitutions on metabolism and covalent binding to macromolecules, demonstration of the ring opening and reactivity of the resulting products. Depending on the findings, additional genotoxicity or other studies might be needed.

Specs Code:

M

Report: 

Specification: 

Comments:

The Committee took note of the extensive positive genotoxicity data for several members of this group of flavouring agents related to furan. Furan, which is carcinogenic, is known to undergo epoxidation and ring opening to form a reactive 2-ene-1,4-dicarbonyl intermediate. Accordingly, concern arises that the observed genotoxicity may be due to formation of a reactive metabolite. Data on the potential of members of this group to form a reactive metabolite were not available and the role of metabolism in the observed genotoxicity has not been identified. Moreover, there was a paucity of in vivo genotoxicity data to allay concern. Also, specific in vivo assays to address potential carcinogenicity were lacking. Because of these concerns, the Committee concluded that the Procedure for the Safety Evaluation of Flavouring Agents could not be applied to this group.

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