Registration Dossier

Administrative data

Description of key information

The substance does not show skin sensitisation in the LLNA.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitising potential of the substance was assessed using the radioactive Murine Local Lymph Node Assay (LLNA) (BASF, 58H0054/082061, 2009). Groups of 5 female CBA/J mice each were treated with 10%, 30% and 50% w/w preparations of the test substance in 1% aqueous Pluronic or with the vehicle alone. The 50% test substance preparation was the maximum soluble concentration in 1% aqueous Pluronic. Each test animal was applied with 25 μL per ear of the respective test-substance preparation to the dorsum of both ears for three consecutive days. The control group was treated with 25 μL per ear of the vehicle alone.

Three days after the last application the mice were injected intravenously with 20 μCi of ³H-thymidine in 250 μL of sterile saline into a tail vein. About 5 hours after the ³H-thymidine injection, the mice were sacrificed and the auricular lymph nodes were removed. The weights of each animal’s pooled lymph nodes were determined. Thereafter lymph nodes were pooled group wise and further evaluated by measuring their cellular content and ³H-thymidine incorporation into the lymph node cells (indicators of cell proliferation). Moreover, a defined area with a diameter of 0.8 cm was punched out of the apical part of each ear and for each test group the weight of the pooled punches was determined in order to obtain an indication of possible skin irritation.

No signs of systemic toxicity were noticed. When applied as 10%, 30% and 50% preparations in 1% aqueous Pluronic, the test substance did not induce a biologically relevant response (increase to 1.5 fold or above of control value = stimulation index (SI) ≥ 1.5) in the auricular lymph node cell counts. There was no relevant increase in lymph node weights, as well. Concomitantly, the increase of ³H-thymidine incorporation into the cells was not biologically relevant (no increase above the cut off stimulation index of 3 was observed) at these concentrations. The test-substance preparations did not cause an increase in ear weights.

Thus it is concluded that the substance does not show a skin sensitising effect in the LLNA under the test conditions chosen.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin sensitisation, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP).