Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.