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Administrative data

Description of key information

In an in vivo study according to the OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay), no skin sensitizing potential of the test substance was observed (BASF SE, 2009).

Key value for chemical safety assessment

Skin sensitisation

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

Skin sensitisation

In the available study conducted according to the OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay), the skin sensitizing potential of the test substance (TS) was assessed by treating groups of 5 female CBA/J mice with a 30 % w/w preparation of the test substance in propylene glycol or with the vehicle alone (the 30 % preparation was the maximum technically applicable concentration). Each test animal was applied with 25 μL per ear of the test substance preparation or vehicle to the dorsum of both ears for three consecutive days. 3 days after the last application the mice were injected intravenously with 20 μCi of [3]H-thymidine in 250 μL of sterile saline into a tail vein. About 5 hours thereafter, the mice were sacrificed and the auricular lymph nodes were removed. The weights of each animal pooled lymph nodes were determined. Lymph nodes were then pooled group wise and further evaluated by measuring their cellular content and [3]H-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.

The stimulation indices (SI; i.e. fold of change as compared to the vehicle control) for cell count, [3]H-thymidine incorporation, lymph node weight and ear weight are summarized below:

 

Test group

Treatment

Cell count SI

[3]H-thymidine incorporation SI

Lymph node weight SI

Ear weight SI

1

vehicle propylene glycol

1.00

1.00

1.00

1.00

2

30 % TS in propylene glycol

1.31

2.33

1.12

1.08

 

When applied as 30 % preparation in propylene glycol, the test substance did not induce a biologically relevant response in the auricular lymph node cell counts (SI = 1.31; cut off value: 1.5). Concomitantly, the increase of [3]H-thymidine incorporation into the cells (SI = 2.33) was not biologically relevant (no increase above the cut off stimulation index of 3). Furthermore, there was no relevant increase in lymph node weights.  

The test-substance preparation caused some increase in ear weights indicating ear skin irritation. The ears of all animals showed a yellow discoloration on study days 1 and 2 and on the day of lymph node removal. No signs of systemic toxicity were noticed

Thus, it is concluded that the test substance does not show a skin sensitizing effect in the Murine Local Lymph Node Assay under the test conditions chosen.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for sensitisation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.