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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
EC number: 204-482-5 | CAS number: 121-57-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In a study (Chung 1981), being reliable with restrictions, conducted similar to OECD test guideline 471, the registered substance was negative, This result is supported by a second study (Chung 1978).
In a GLP-study according to OECD test guideline 473, the registered substance was negative as it did not induce chromosomal aberrations.
In a GLP-study according to OECD test guideline 476, the registered substance was negative as it did not induce biologically relevant mutations.
These negtive results are supported by an in vivo study:
FD & C Yellow No. 6, which is rapidly and almost completely metabolised in the gut inter alia to sulphanilic acid, i.e. the registered substance, gave a negative result in both rat and mouse bone marrow micronucleus tests after a single oral dose of up to 2000 mg/kg.
In summary, the registered substance is considered not be genetically toxic.
Short description of key information:
Bacterial reverse mutation assay (Ames): negative
Chromosomal aberration: negative
HPRT: negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on in vitro and in vivo data, the registered substance has not to be classified for genetic toxicity and mutagenicity.
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.
