Registration Dossier

Administrative data

Description of key information

Direct Blue 080 was tested for bacteria gene mutation and resulted as non mutagenic for all the Salmonella typhimurium as well as Escherichia coli strains with and without metabolic activation. Being the Ames test a screening test, giving important information about one of the key event that can lead to the carcinogenicity endpoint, it is difficult to support an alert for carcinogenicity.

We are aware that an alert on benzidine functional group is contained in the molecule, but the complexation with copper makes the availability of the group very unlikely. The substance has been tested under reduction conditions (see the analytical identification section) and no release of benzidine has been measured over 10 ppm.

Therefore the substance can be considered of no concern

Key value for chemical safety assessment

Additional information

Justification for classification or non-classification