Registration Dossier

Administrative data

Description of key information

Non skin sensitizer.

Key value for chemical safety assessment

Skin sensitisation

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

4-anilinobenzenediazonium hydrogen sulphate was tested in "Lusens test" on the basis to the protocol “LuSens Assay” provided by BASF SE and the OECD Guideline 442D. This test investigates the Key Event 2 (i.e. Keratinocyte response) in the skin sensitisation pathway. In all tested concentrations of the test item for both experiments no substantial and reproducible dose dependent increase of luciferase induction above 1.5 was measured. In conclusion 4-anilinobenzenediazonium hydrogen sulphate is not considered as a potential sensitizer. Combining the result of LuSens test with consideration on physico-chemical properties of the test item, QSAR predictions, information from similar substances and human data available , it is possible to conclude that is not skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the CLP Regulation (EC n.1272/2008), Skin sensitiser means a substance that will lead to an allergic response following skin contact. The skin sensitisation potential was investigated according to EU Regulation 2016/1688 - updated regarding skin sensitisation requirement of annex VII of the REACH regulation (EC n. 1907/2006) in force since 11th October 2016. The biological mechanisms of skin sensitisation is a stepwise mechanism (Adverse Outcome Pathway -AOP) that follows these key events: (a) molecular interaction with skin proteins; (b) inflammatory response in keratinocytes; (c) activation of dendritic cells. LuSens test investigates Keratinocyte response. The result of LuSens test on 4-anilinobenzenediazonium hydrogen sulphate was negative. Combining the result of LuSens Test with consideration on physico-chemical properties of the test item, QSAR predictions, information from similar substances and human data available, it is possible to conclude that 4-anilinobenzenediazonium hydrogen sulphate is not skin sensitiser according to the CLP Regulation (EC. n.1272/2008).