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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-121-9 | CAS number: 103-54-8
Endpoint summary
Administrative data
Description of key information
Two studies are available to assess the skin sensitising potential of the test substance: a Direct Peptide Reactivity Assay (DPRA) study and an in vitro Human Cell Line Activation Test (h-CLAT) study. It concerns recent OECD and GLP compliant studies. The test item was found to be non-sensitising in both studies.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There are two studies available for the current endpoint.
In the first study the skin sensitisation effect of the test item was assessed in the Direct Peptide Reactivity Assay (DPRA) in chemico assay according to OECD 442C and GLP. The mean C-peptide depletion was found to be 2.52% and the mean K-peptide depletion 1.59%. Following the depletion model the reactivity class is 'no to minimal reactivity' and the DPRA prediction is negative. Under the current conditions the test item is not a sensitiser.
In the second study an in vitro Human Cell Line Activation Test (h-CLAT) was performed to assess the skin sensitising potential of the test item dissolved in culture medium when administered to THP-1 cells for 24 ± 0.5 hours. The test was performed in accordance to the OECD test guideline 442E and under GLP. The test item with a log Pow of 2.7 did not activate THP-1 cells up to a concentration of 156.3 μg/mL (limited by precipitation, oily droplets) under the test conditions of this study. Therefore the test item is considered to be negative for this key event of the skin sensitisation Adverse Outcome Pathway (AOP).
Based on the above it is apparent that in vitro testing towards two out of the three key events yielded a negative result. Hence, the test item is not considered to be a skin sensitizer. Further in vitro or in vivo testing is not needed.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Taking into account the results of the available in vitro and in vivo tests, the test item is not considered to be as a skin sensitiser.
The available data on skin sensitisation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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.
