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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 local Iymph node assay was performed using test item concentrations of 25, 50, and 100% (w/v). The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (Si.) ) of 0.60, 0.90, 0.20 were determined with the test item at concentrations of 25, 50, and 100 % (w/v) in acetone:olive oil (4 +1), respectively. The test item was not a skin sensitiser in this assay.


Migrated from Short description of key information:
A local Iymph node assay was performed using test item concentrations of 25, 50, and 100% (w/v). The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (Si.) ) of 0.60, 0.90, 0.20 were determined with the test item at concentrations of 25, 50, and 100 % (w/v) in acetone:olive oil (4 +1), respectively. The test item was not a skin sensitiser in this assay.

Justification for selection of skin sensitisation endpoint:
Well perfromed study, in agreement with GLP requirements

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Even though there is no study for the assessment of respiratory sensitisation, the available study on skin sensitisation may exclude the sensitisation through respiratory airway.

In fact, myristil trisiloxane has a lower MW and high lipophilicity and therefore high skin absorption may be reasonably assumed. Due to the high viscosity and low vapour pressure, it can be assumed that exposure via air ways should be lower than through the skin. If a skin test is negative with a high skin absorption rate, there is no reason to assume that the behviour can be different in the respiratory system.

Justification for classification or non-classification

Based on regulation REGULATION (EC) No 1272/2008 "Skin sensitiser means a substance that will lead to an allergic response following skin contact", test item Myristyl Trisiloxane needs no classification.

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