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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitising properties of Amides, C18, branched and linear were tested in a study according to OECD TG 429 under GLP conditions using the local lymph node assay (LLNA) (Bradshaw, 2015). In this study groups of four female CBA/CaOlaHsd mice were treated with the test item at concentrations of 2.5, 5 and 10% (w/w) (highest achievable concentration tested in a preliminary study). Topical application of 25 µL of the appropriate test substance concentrations was performed daily at the dorsal surface of each ear for three consecutive days. Five days following the first topical application of the test item or vehicle all mice were injected via the tail vain with 250 µL PBS containing 3H-methylthymidine (20 µCi per mouse). Five hours after injection single cell suspension of pooled lymph nodes was prepared of each group, followed by determination of3HTdR incorporation. Positive and negative controls were included in the study and gave the expected results. The calculated stimulation indices (SI) of the test substance are 0.63, 0.78 and 1.68 at concentrations of 2.5, 5 and 10% (w/w), respectively, and therefore < 3. Thus, under the conditions of the test, the test substance can be considered as a non-sensitiser.
Migrated from Short description of key information:
Skin sensitisation (LLNA - OECD 429): not sensitising
Justification for selection of skin sensitisation endpoint:
The reliable GLP compliant OECD Guideline study was chosen.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on the skin sensitisation of Amides, C18, branched and linear do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC, 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.
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