Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
Reaction mass of sodium(E)-6,7'-carbonylbis(azanediyl)bis(4-hydroxy-3-((E)-phenyldiazenyl) naphthalene-2-sulfonate) and disodium 3-[(4-acetamidophenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulphonato-2-naphthyl]amino]carbonyl]amino]naphthalene-2-sulphonate and disodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-(phenylazo)naphthalene-2-sulphonate]
EC number: 939-268-7 | CAS number: -
Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
