Registration Dossier
Registration Dossier
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EC number: 218-407-9 | CAS number: 2144-53-8
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:
A mouse local lymph node assay was conducted at 0% (vehicle control), 5%, 25%, 50%, or 100% of test substance. Although, statistically significant increases in cell proliferation measurements compared to the vehicle control group were observed at the 100% test concentrations, stimulation indices (SIs) of less than 3.0 were observed at all test concentrations of the test substance. Therefore, the EC3 value (the estimated concentration required to induce a threshold positive response, i. e., SI = 3) for the test substance under the conditions of this study was not calculable. A 25% concentration of the positive control, HCA, produced a dermal sensitization response in mice. Therefore, the LLNA test system was valid for this study with the test substance. Under the conditions of this study, the test substance did not produce a dermal sensitization response in mice. Based on these data, the test substance is not a dermal sensitizer in mice.
Migrated from Short description of key information:
OECD 429; no sensitization was observed in mice (LLNA). Reliability = 1
Justification for selection of skin sensitisation endpoint:
OECD guideline, GLP study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
There was no evidence of dermal sensitization in a mouse local lymph node assay. The substance does not need to be classified for skin sensitization according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 (ATP02).
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