Scientific Opinion of Flavouring Group Evaluation 407 (FGE.407): 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid

Vittorio Silano, Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler , Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Maria Rosaria Milana, André Penninks, Maria de Fátima Tavares Poças, Andrew Smith, Christina Tlustos, Detlef Wölfle , Holger Zorn, Corina-Aurelia Zugravu, Ulla Beckman SundhLeon Brimer, Gerard Mulder, Maria Anastassiadou, Wim Mennes, EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

Research output: Contribution to specialist publicationArticle

7 Downloads (Pure)

Abstract

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid [FL-no: 16.130], in the Flavouring Group Evaluation 407 (FGE.407), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intended to be used as both the parent compound and its hemisulfate monohydrate salt as a flavouring substance with modifying properties in specific categories of food. The chronic dietary exposure to the substance estimated using the added portions exposure technique (APET), is calculated to be 882 μg/person per day for a 60-kg adult and 547 μg/person per day for a 15-kg 3-year-old child. There is no concern with respect to genotoxicity. A 90-day dietary administration study in rats showed no adverse effects for doses up to 100 mg/kg body weight (bw) per day, providing an adequate margin of safety. Developmental toxicity was not observed in a study with rats at the dose levels up to 1,000 mg/kg bw per day. The Panel concluded that [FL-no: 16.130] and its hemisulfate monohydrate salt are not expected to be of safety concern at the estimated levels of dietary exposure calculated using the APET approach. This conclusion applies only to the use of the substance as a flavour modifier as requested and when used at the levels as specified for foods from different food categories.
Original languageEnglish
Pagese04660
Volume15
No.1
Specialist publicationEFSA Journal
PublisherEuropean Food Safety Authority (EFSA)
DOIs
Publication statusPublished - Jan 2017

Keywords

  • 4-amino-5-(3-(isopropylamino)-2; 2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid
  • FGE.407; [FL-no: 16.130]

Fingerprint Dive into the research topics of 'Scientific Opinion of Flavouring Group Evaluation 407 (FGE.407): 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid'. Together they form a unique fingerprint.

  • Cite this

    Silano, V., Bolognesi, C., Castle, L., Cravedi, J-P., Engel, K-H., Fowler , P., Franz, R., Grob, K., Gürtler, R., Husøy, T., Kärenlampi, S., Rosaria Milana, M., Penninks, A., de Fátima Tavares Poças, M., Smith, A., Tlustos, C., Wölfle , D., Zorn, H., Zugravu, C-A., ... EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) (2017). Scientific Opinion of Flavouring Group Evaluation 407 (FGE.407): 4-amino-5-(3-(isopropylamino)-2,2-dimethyl-3-oxopropoxy)-2-methylquinoline-3-carboxylic acid. EFSA Journal, 15(1), e04660. https://doi.org/10.2903/j.efsa.2017.4660