The Panel noted that Red 2G is extensively metabolised to aniline. The Panel noted that the current genotoxicity and carcinogenicity databases on Red 2G and its metabolite, aniline, are limited. However both genotoxic and carcinogenic effects have been observed in rodents treated with aniline. The Panel based its evaluation on the conclusions of the EU Risk Assessment on aniline. This concluded that aniline should be considered as a carcinogen for which a genotoxic mechanism cannot be excluded, based on the following: - aniline was genotoxic in vivo in rats and mice, - there was insufficient mechanistic evidence to discount a genotoxic mechanism for the rodent carcinogenicity, - based on similar metabolism of aniline in animals and humans a carcinogenic risk for man cannot therefore be excluded. Therefore the Panel concluded that it would be prudent to regard Red 2G as being of safety concern since it is extensively metabolised to aniline. Based on these considerations, the Panel withdrew the ADI for Red 2G.
The food colour Red 2G (E128)
GRILLI, SANDRO;
2007
Abstract
The Panel noted that Red 2G is extensively metabolised to aniline. The Panel noted that the current genotoxicity and carcinogenicity databases on Red 2G and its metabolite, aniline, are limited. However both genotoxic and carcinogenic effects have been observed in rodents treated with aniline. The Panel based its evaluation on the conclusions of the EU Risk Assessment on aniline. This concluded that aniline should be considered as a carcinogen for which a genotoxic mechanism cannot be excluded, based on the following: - aniline was genotoxic in vivo in rats and mice, - there was insufficient mechanistic evidence to discount a genotoxic mechanism for the rodent carcinogenicity, - based on similar metabolism of aniline in animals and humans a carcinogenic risk for man cannot therefore be excluded. Therefore the Panel concluded that it would be prudent to regard Red 2G as being of safety concern since it is extensively metabolised to aniline. Based on these considerations, the Panel withdrew the ADI for Red 2G.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
