Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
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 byflow 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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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