Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

No experimental data about genetic toxicity of the test substance are available. But there are several data from study reports, public journals and other literature sources which describe and characterize sulfanilic acid as well as the sodium salt.It is acceptable to derive genetic toxicity from experimental data of sulfanilic acid and the sodium analogue. The potassium salt as well as the sodium salt dissociates in aqueous solution in free sulfanilic acid and the respective ions.

Sulfanilic acid was tested in several Ames tests and found to be negative in this test system. Moreover, there are no strucutral hints for mutagenic potential. Therefore, the test substance is considered to be not mutagenic in Ames test.


Short description of key information:
No experimental data about genetic toxicity of the test substance are available. Sulfanilic acid was tested in several Ames tests and found to be negative in this test system. Moreover, there are no strucutral hints for mutagenic potential. Therefore, the test substance is considered to be not mutagenic in Ames test.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for genotoxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for genotoxicity under Regulation (EC) No. 1272/2008.