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:

A skin sensitization test according to OECD 429 was performed with (N-Morpholinomethyl)triethoxysilane. The radioactive Murine Local Lymph Node 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/Ca01aHsd mice each were treated with 10%, 50% and 100% v/v preparations of the test substance in Acetone/Olive Oil (3:1 v/v) or with the vehicle alone. No signs of systemic toxicity were noticed. When applied as 10% and 50% preparation in acetone/olive oil (3:1 v/v), the test substance did not induce relevant changes in the ³H-methyl thymidine incorporation. The 100% test substance preparation caused slight but not concentration related increase in 3H-thymidine incorporation into the lymph node cells, which failed to reach the cut off stimulation index (increase to 3 fold or above of control value = stimulation index (SI) ≥ 3) and thus lie below the threshold of immunologic relevance. In addition there was no relevant increase in lymph node weights. Thus it is concluded that the test item does not show a skin sensitizing effect in the Murine Local Lymph Node Assay under the test conditions chosen.

Respiratory sensitisation

Endpoint conclusion
Additional information:

No data available.

Justification for classification or non-classification

Based on the reliable data provided for this endpoint (N-Morpholinomethyl)triethoxysilane needs not to be classified as a sensitizer.