Registration Dossier

Administrative data

Description of key information

Not skin sensitizer.

Key value for chemical safety assessment

Skin sensitisation

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

The solid substance was tested by h-CLAT assay conducted according to OECD TG 442E:2016. The test was carried out on the human cell line THP-1, in two independent runs. Cells were exposed to 8 different concentrations of the test chemical for 24 hours. CD54/CD86 over-expression, strictly related to the sensitizing potential of the test substance, was assessed byow cytometry. Under the test conditions above described, the test substance resulted to be NEGATIVE (NON-SENSITIZER) up to the maximal tested concentration of 1000 μg/ml. The non sensitisation potential of the test item was confirmed also by epidemiological studies (see section 7.10.4 of this IUCLID dossier).

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. h-CLAT test investigates Monocytic /Dendritic cell response. The result of h-CLAT on solid test item was negative. The result of h-CLAT test combined with available epidemiological studies are considered enough to conclude that the substance is not skin sensitiser according to the CLP Regulation (EC n. 1272/2008).