Registration Dossier
Registration Dossier
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EC number: 280-676-3 | CAS number: 83733-23-7
Endpoint summary
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:
A guinea pig maximization study was conducted with the structural analogue substance Acid Red 315 to evaluate the skin sensitization potential of the test substance (of 80% purity) according to OECD Guideline 406 and EU Method B.6 with few deviations. Based on the results of a preliminary study, 5 and 50% were selected as intradermal and topical induction doses respectively. The highest non-irritating test substance concentration used for challenge application was 50%.
After the first challenge, positive skin reactions were observed in the control group. Therefore a second challenge was performed with an additional control group. The test substance at 50% in vaselinum album was determined twice as the highest non-irritating concentration. However by comparison, the second challenge did not confirm the first challenge with the test article at 50% and the interpretation is therefore very ambiguous. Further, an additional test substance concentration of 25% was applied in the second challenge procedure. No skin reactions were observed in the control and test group at test substance concentration of 25%.
Under the conditions of the study, the test substance was not considered to induce delayed contact hypersensitivity in treated animals when tested at the concentration of 25%.
The test substance did not show significant potential to be a skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitisation:
Based on the above stated assessment of the skin sensitisation potential, the substance does not need to be classified as a skin sensitizer according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council) as implementation of UN-GHS in the EU.
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