Registration Dossier

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:

In a GLP complaint Local Lymph Node Assay, according to OECD guideline 429, the potential to cause skin sensitization was assessed by applying the test substance Decyloxirane to the dorsal skin of CBA mice at concentrations of 2, 5 an 10% dissolved in acetone/olive oil (4:1 v/v).The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation (as determined by two pre-experiments). In this study Stimulation Indices (S.I.) of 0.68, 0.92, and 2.92 were determined with the test item at concentrations of 2, 5, and 10% in acetone/olive oil (4+1, v/v), respectively. A dose response was observed. The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3. The test substance was therefore not considered to be a skin sensitizer.

Migrated from Short description of key information:
The test substance was not skin sensitizing in a LLNA study.

Justification for selection of skin sensitisation endpoint:
There is only one study available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substance was not skin sensitizing in the LLNA study. Classification for skin sensitization is therefore not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.