Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

Overall, the genotoxicity of HC Blue 16 is sufficiently investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. HC Blue 16 induced gene mutations both in a gene mutation test in bacteria and in a mouse lymphoma assay in mammalian cells. In an in-vivo micronucleus test in mice an increase in bone marrow cells with micronuclei was not found. The positive findings from the in-vitro tests for gene mutations were not confirmed in in-vivo tests. In a Comet assay, a test nowadays considered as indicative for both clastogenic (chromosome breaks) and mutagenic (gene mutations) effects, an increase in tail length in cells of the liver, stomach and urinary bladder was not observed. Consequently, on the basis of these tests, HC Blue 16 can be considered to have no genotoxic potential and additional tests are unnecessary.