TABLE D.1 Summary of newly submitted in vitro genotoxicity studies on naringenin (Documentation provided to EFSA No. 2 and 3).

Chemical name [FL‐no]	Test system in vitro	Test object	Concentrations a and test conditions	Result	Reliability/comments	Relevance of test system/relevance of the result	Reference
Naringenin [16.132]	Reverse Mutation test	S. Typhimurium TA98, TA100, TA102, TA1535, TA1537 E. Coli WP2 uvrA	Experiment 1: 1.5–5000 μg/plate (+/− S9, plate incorporation)	Negative	Reliable without restrictions Study performed according to OECD TG 471 and in compliance with GLP	High/High	Envigo Research Limited (2018a)
			Experiment 2: 1.5–5000 μg/plate (+/− S9, pre‐incubation)
	Micronucleus assay with FISH analysis	Human peripheral blood lymphocytes	125, 150, 200, 250 μg/mL (4 h + 24 h, –S9)	Positive FISH analysis indicates that naringenin induced micronuclei by a clastogenic mechanism	Reliable without restrictions. Study performed according to OECD TG 487 and in compliance with GLP	High/High	Envigo Research Limited (2018b)
			125, 150, 200 μg/mL (4 h + 24 h, +S9)
			100, 125, 150 μg/mL (24 h + 24 h, –S9)

Abbreviations: FISH, fluorescence in situ hybridisation; GLP, good laboratory practice; OECD, Organisation for Economic Co‐operation and Development.

^a For the in vitro MN study, the given concentrations are those for the cultures that were scored for micronuclei.