Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

The skin sensitizing potential of the test substance was assessed using the radioactive Murine Local Lymph Node Assay (OECD 429 guideline). The assay simulates the induction phase for skin sensitization in mice. It determines the response of the auricular lymph nodes on repeated application of the test substance to the dorsal skin of the ears. Groups of 5 female CBA/J mice each were treated with 3%, 10% and 30% w/w preparations of the test substance in MEK (methyl ethyl ketone) or with the vehicle alone. The study used 3 test groups and 1 control group. 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.

The test substance induced a concentration dependent response in the auricular lymph node cell counts, which was biologically relevant (increase to 1.5 fold or above of control value = stimulation index (SI) ≥ 1.5) when applied as 10% and 30% preparations in MEK.

There was a concentration dependent increase in lymph node weights as well.

Concomitantly, the increase of 3H-thymidine incorporation into the cells was concentration dependent and biologically relevant (increase above the cut off stimulation index of 3) at the above mentioned concentrations.

The 3% and 10% test-substance preparations caused some increase and the 30% preparation a severe increase in ear weights. Scaling on the ears was observed on the day of lymph node removal in the 10% and 30% test substance groups.

Although the magnitude of ear skin irritation in the 30% test-substance group might have influenced the lymph node reaction, the considerable increase in the cell count and 3Hthymidine incorporation indices cannot be explained by irritation alone.

Thus it is concluded that the test substance shows a skin sensitizing effect in the Murine Local Lymph Node Assay under the test conditions chosen.

The threshold concentration for sensitization induction was >3% <10%. The estimated concentration that leads to the SI of 1.5 for cell count (EC 1.5) and the estimated concentration that leads to the SI of 3.0 for 3H-thymidine incorporation (EC 3) was calculated

by linear regression from the results of the 3% and 10% concentrations to be 6.8% and 3.5%, respectively.

Migrated from Short description of key information:
LLNA: sensitising (BASF SE, 2009)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available LLNA data, the test substance is considered to be a skin sensitiser and has to be labelled with R43/CLP Cat.1 (skin sensitisation) according to 67/548/EWG and 1272/2008/EG (CLP).