Registration Dossier

Administrative data

Description of key information

NOAEL = 500 mg/kg bw/day

LOAEL = 1500 mg/kg bw/day

Key value for chemical safety assessment

Additional information

Many repeated oral toxicity studies regarding E131 Patent blue V on different animal species (rats, dogs and cats) are available. None of these studies is raising concern. Considering literature information regarding repeated oral toxicity of E131 Patent blue V on rats, the NOAEL in a 9-week study was set at 500 mg/kg bw/day (IFREB. Carcinogenicity study in the OFI mouse with colouring agent E 131 Patent Blue. Institut Français de Recherches et Essais Biologiques. IFREB Report N°.110203, 1981) since at the higher dose tested body weight reduction and haematological effects were seen (LOAEL = 1500 mg/kg bw/day).

Justification for classification or non-classification

Not classified for repeated dose toxicity according to the CLP Regulation (EC.1272/2008). For justification see additional information.