. 2019 Jul 17;17(7):e05750. doi: 10.2903/j.efsa.2019.5750

Table C.1.

Summary of in vitro genotoxicity data evaluated in FGE.204

FL‐no	Chemical Name	Test System in vitro	Test Object	Concentrations of Substance and Test Conditions	Result	Reference	Comments
07.101	4‐Methylpent‐3‐en‐2‐one	Reverse mutation	Salmonella Typhimurium TA98, TA100, TA102, TA1535 and TA1537	1.6–5,000 μg/platea	Negative	Williams (2009)	Valid. Study design complies with current recommendations
		Reverse mutation		156.25–5,000 μg/platea ^, b	Negative	Williams (2009)	Valid. Study design complies with current recommendations
		Micronucleus assay	Human peripheral blood lymphocytes	600–981.4 μg/mLc	Negative	Stone (2011)	Valid Complies with OECD Guideline 487
				200–981.4 μg/mLd	Negative
				100–500 μg/mLd	Negative
				100–300 μg/mLe	Negative
07.177	7‐methyl‐3‐octenone‐2	Reverse mutation	S. Typhimurium TA102	1.6–5,000 μg/platea	Negative	Ballantyne (2011)	Valid. Studies combined comply with current recommendations
			S. Typhimurium TA102	51.2–5,000 μg/platea ^, b	Negative	Ballantyne (2011)	Valid. Studies combined comply with current recommendations
			S. Typhimurium TA98, TA100, TA1535, TA1537, and TA1538	15–5,000 μg/platea	Negative	Thompson (1996)
		Micronucleus assay	Human peripheral Blood lymphocytes	5–15 μg/mLc	Equivocal	Lloyd (2009)	Valid Testing strategies including FISH analyses for determination of potential clastogenicity or aneugenicity. The study complies with OECD Guideline 487
				30–60 μg/mLd	Equivocal
				2–6 μg/mLe	Positive
				5.5–8 μg/mLe	Positive	Lloyd (2010)

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

With and without S9‐mix metabolic activation.

Assay modified with pre‐incubation in the presence of S9‐mix.

Without metabolic activation, 3 h treatment + 21 h recovery.

With metabolic activation, 3 h treatment + 21 h recovery.

Without metabolic activation, 24 h + 0 h recovery.

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).