Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a GLP compliant study according to OECD guideline 429 3 -aminobenzenesulfonic acid formulated in dimethylsulfoxide was assessed for its possible skin sensitising potential (Harlan CCR 2012). For this purpose a local lymph node assay was performed using test item concentrations of 0.05, 0.1 and 0.25% (w/w). The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by three pre-experiments. The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. On day 2 a very slight erythema of the ears was observed in the animals treated with 0.25% of the test item (score: 1). On day 4, a very slight erythema of the ears was observed in all treatment groups (score: 1). Moreover, a statistically significant increase in ear weights was observed in the animals treated with 0.25% of the test item, indicating an irritation potential of the test item. In this study Stimulation Indices (S.I.) of 0.87, 0.97 and 0.78 were determined with the test item at concentrations of 0.05, 0.1 and 0.25% (w/w) in dimethylsulfoxide, respectively. A dose response was not observed. 3 -Aminobenzenesulfonic acid was not a skin sensitiser under the test conditions of this study.


Migrated from Short description of key information:
3-Aminobenzenesulfonic acid was not a skin sensitiser under the test conditions of this LLNA study in mice.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data, the substance does not need to be classified for skin sensitisation according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.