Table C.2.

Summary of in vivo genotoxicity data evaluated in FGE.204

FL‐no	Chemical name	Test system in vivo	Test object/Sex No per group/groups	Route	Concentrations of substance	Result	Reference	Comments
07.177	7‐methyl‐3‐octenone‐2	Micronucleus Assay	Male Han Wistar rats/6 animals/group	Gavage on 2 occasions 24 h apart	0, 500, 1,000 and 2,000 mg/kg bw per day	Negative	Henderson (2012)	Valid. Complies with OECD guideline 474. Although the study was performed at the maximum recommended highest dose‐level (2,000 mg/kg) no clear indication of toxicity was observed indicating that test substance might not have been systemically available. This is also supported by positive findings observed in the in vitro micronucleus assay in the absence of S9 metabolism which indicates a direct reactivity of test compound

FGE: Flavouring Group Evaluation; FL‐no: FLAVIS number; FLAVIS: Flavour Information System; OECD: Organisation for Economic Co‐operation and Development.

Validity of genotoxicity studies:

Valid.

Limited validity (e.g. if certain aspects are not in accordance with OECD Guidelines or current standards and/or limited documentation).

Insufficient validity (e.g. if main aspects are not in accordance with any recognised guidelines (e.g. OECD) or current standards inappropriate/not validated test system).

Validity cannot be evaluated (e.g. insufficient documentation, short abstract only, too little experimental details provided, text not in a Community language).