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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

No experimental data about skin or respiratory sensitisation by test material 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 sensitising properties 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.

In several tests in guinea pig and mouse, sulfanilic acid is described to be sensitising to skin. It is assumed that N-acetylation of sulfanilic acid leads to an immune reaction and, therefore, to IgE-formation. Thus, also the test substance is considered to be sensitising and classified with R43, Xi.


Migrated from Short description of key information:
In several tests in guinea pig and mouse, sulfanilic acid is described to be sensitising to skin. It is assumed that N-acetylation of sulfanilic acid leads to an immune reaction and, therefore, to IgE-formation. Thus, also the test substance is considered to be sensitising and classified with R43, Xi.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies for read across substances are considered reliable and suitable for classification purposes under 67/548/EEC. It was shown that the read across substances cause sensitisation of the skin. As a result the substance is considered to be classified for skin sensitization 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 for read across substances are reliable and suitable for classification purposes under Regulation 1272/2008. It was shown that the read across substances cause sensitisation of the skin. As a result the substance is considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008.