Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

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

Genetic toxicity in vivo

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

Additional information

An in vivo mutagenicity tests is available for Direct Black 80.

An Ames test followiing OECD 471  is available on a similar substance 5 and negative.

The results of the mammalian cell gene mutation assay (OECD 476) and the in vivo micronucleous assay (OECD 474), made on the similar substance 2, are both negative.

In addiction also the in vivo micronucleus (bone marrow) test, made on Direct Black 80, following NTP guideline, showed negative results.

Based on these tests, the Direct Black 80 could be considered as not mutagenic.

Short description of key information:

Not mutagenic

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

This hazard class is primarily concerned with substances that may cause mutations in the germ cells of humans that can be transmitted to the progeny. However, the results from mutagenicity or genotoxicity tests in vitro and in mammalian somatic and germ cells in vivo are also considered in classifying substances and mixtures within this hazard class.

For the purpose of classification for germ cell mutagenicity, substances are classified if there is at least positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:

— somatic cell mutagenicity tests in vivo, in mammals; or

— other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.

The presented results from in vivo and the in vitro tests are negative, therefore it is concluded that Direct Black 80 is not genotoxic with or without metabolic activation.