Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
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.
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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