Registration Dossier
Registration Dossier
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EC number: 288-003-5 | CAS number: 85631-54-5
Endpoint summary
Administrative data
Description of key information
Not sensitising
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), 10%, 25% or 50% (w/w) of test substance registered. All treated animals survived the scheduled study period and no signs of systemic toxicity or local irritation were observed. In this study Stimulation Indices of 1.06, 1.00 and 1.27 were determined with the test item at concentrations of 10%, 25% or 50% (w/w) in MEK. No dose response was observed. The EC3 value (the estimated concentration required to induce a threshold positive response, i. e., SI = 3) could not be calculated under the conditions of this study, since none of the tested concentrations induces a S.I. greater than the value of 3. A 25 % (w/w) concentration of the positive control Z-Hexylcinnamaldehyde produced a dermal sensitization response in the mice. Therefore, the 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.
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 the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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