Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

Numerous patient cohorts and occupationally exposed persons clearly reacted positively to 4-Aminoazobenzene in concentrations of 0.25 - 2 % in vaseline or methylethylketone in the epicutaneous test. Moreover, several case descriptions exist in which positive reactions by 4-Aminoazobenzene in concentrations of 0.25 - 5 % could be triggered in individuals with dermatitis (Conde-Salazar et al., 1995; Kousa and Soini, 1980; BUA, 1998). No animal study with relevance for evaluation exists.

Justification for classification or non-classification

Based on human evidence of postive skin reactions, positive structural alert for skin sensitisation (aromatic amine) as well as classification of structurally related substances (i.e. aniline) classification of 4 -aminoazobenzene as skin sensitizer according to both Annex VI to 67/548/EEC and Annex I to the CLP-regulation is warranted.