Table E.1.

Toxicity studies considered in FGE.70Rev1 as summarised by JECFA (2004b)

EU Union List Name [FL‐no]	Species; Sex No./Group	Route	Dose levels (mg/kg bw per day)	Duration	NO(A)EL (mg/kg bw per day)	Reference	EFSA Comments
2‐trans‐6‐cis‐Dodecadienal [FL‐no:05.120] 2‐trans‐4‐cis‐7‐cis‐Tridecatrienal [FL‐no:05.064]	Rats; Male, Female 6/sex per group	Diet (microencapsulated in maltodextrin)	0 (maltodextrin), [FL‐no:05.120]: up to 1.93 and 2.06 for males and females, respectively [FL‐no:05.064]: up to 30.9 and 33 males and females, respectively	4 weeks	[FL‐no:05.120]: 2.06 [FL‐no:05.064]: 33	Edwards (1973)	This study of short duration on the mixture is not suitable for the evaluation of flavouring substances
Hexa‐2(trans),4(trans)‐dienal [05.057]	F344/N rats; male and female, 10/sex per group	Gavage	0, 7.5, 15, 30, 60 and 120	14 weeks	15 for male rats 60 for female rats	NTP (2003)	Based on the magnitude of the observed effect (body weight changes), the Panel considered the NOAEL in rats in this study to be 60 mg/kg bw per day
	B6C3F1 mice male and female, 10/sex per group	Gavage	0, 7.5, 15, 30, 60 and 120		30 for male mice		JECFA did not derive a NOEL for female mice owing to the increased relative liver weights observed at all doses. However, the Panel noted that there was no indication of histopathological or clinical changes at all doses
Deca‐2(trans),4(trans)‐dienal [FL‐no: 05.140]	Rats; Male, Female 10/sex per group	Gavage	0, 50, 100, 200, 400 and 800 in corn oil (dosing volume: 5 ml/kg)	14 weeks	100	NTP (2011)	The study has actually been performed during 1996/1997
	Mice; Male, Female 10/sex per group	Gavage	0, 50, 100, 200, 400 and 800 in corn oil (dosing volume: 10 ml/kg)		100

bw: body weight; NOAEL: no observed adverse effect level; JECFA: The Joint FAO/WHO Expert Committee on Food Additives.