Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 254-991-1 | CAS number: 40594-65-8
Endpoint summary
Administrative data
Description of key information
non-skin sensitiser
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The sensitising potential of the substance was evaluated in-vitro by quantifying the changes of cell surface marker expression (CD80, CD86) on a human monocytic leukemia cell line, THP-1 cells, following 48 hours exposure to the two concentrations of the test substance. The changes of surface marker expression were measured by a flow cytofluorimeter following cell staining with fluoresceinated antibodies. A preliminary cytotoxicity measurement (MTT assay) was also conducted to determine the non-cytotoxic concetrations to be used in the sensitisation assay. The Mean Fluorescence Intensity (MFI) of surface markers for the test material and positive control (nickel sulphate) compared to negative control were calculated. The results of nickel sulphate is characterised by a) high increase of both the markers; b) direct correlation between concentration and intensity of the response; c) relevant effects even at very low doses (4 μg/ml). The sample did not cause any increase in the expression of the markers CD80 and CD86. Comparing the behaviour of the positive substance and the test material it is deemed that the substance does not have sensitising potential.
Further evaluation of the sensitising potential of the substance by considering data on analogue substances and on predicted skin metabolites, supports the non sensitising potential of the substance.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance was evaluated whether it upregulates the expression of the cell surface markers CD80 and CD86. No classification criteria are available in the CLP Regulation (EC) No. 1272/2008 for the present test however, the substance did not cause any increase in the expression of the two cell surface markers. The skin sensitisation potential of the analogue substances and of substance's predicted skin metabolites was additionally evaluated, supporing the non-classification of the substance as a skin sensitiser.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
