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Description of key information

The h-CLAT test results is clearly positive and no further investigation is deemed necessary.

Key value for chemical safety assessment

Skin sensitisation

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

The substance was tested to assess its sensitising potential according to OECD TG 442E (hCLAT test) by quantifying changes in the expression level of the two cell surface markers CD86 and CD54, which are associated with the process of activation of monocytes and dendritic cells.  In both experiments the RFI of CD86 was > 150 % in all tested non-cytotoxic (viability≥50 %) test item concentrations. In experiment IV also the RFI of CD54 was > 200 % at two non-cytotoxic test item concentrations. Even though a calculation of EC150 and EC200 was no possible, the h-CLAT test result is clearly positive and no further investigation is deemed necessary.

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 may trigger an allergic response following skin contact. The skin sensitisation potential of the substance "Reaction mass of dodecane-1-thiol and tridodecyl trithiophosphite" 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 starting 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 the h-CLAT on the substance was clearly positive and no further investigation was deemed necessary with attribution of classification H317 in a precautionary way. No subcategory definition is possible.