Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

On the base of results Direct Red 23 (DR23) can be considered not mutagen. In vitro Bacterial Gene Mutation (AMES) and chromosomal aberration (in vivo and in vitro) were tested on structural analogues, while Mammalian Gene Mutation (mouse Lymphoma) was tested on DR23. The mouse Lymphoma test has confirmed the no concern also about chromosomal aberration.

All present the same results: no traces of mutagenicity and no significative cytotoxicity. In Ciba 1992 in vitro test cytotoxicity is evidenced in only one strain (TA 1537 at 5000 µg/plate). In Ciba 1992 in vivo test is indicated some cytotoxicity on erythrocytes at the dose level used of 5000 µg/kg.

In conclusion DR23 doesn't meet the criteria for classification as genetic toxicant.


Justification for selection of genetic toxicity endpoint
No selection was made, since the result has been defined based on the comparative assessment of the three in vitro basic required test.

Short description of key information:
Not mutagen

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to CLP regulation (EC1272/2008) Direct Red 23 is not classified for genetic toxicity.