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:

The positive control substance DNCB (Dinitrochlorobenzene) produced positive LLNA response at an exposure level expected to give an increase in the Stimulation Index SI ≥ 3 over the negative control group, which was in congruence with the expected mode of action of a contact allergen. The positive control also elicited a reaction pattern with statistically significant increase in ear weight. The negative control did not reveal any changes.These results demonstrate that the method has sufficient reliability.

The animals exposed to the test substance showed no skin reactions and clinical symptoms of intoxication throughout the experiment.

The test substance did not show a tendency to increased ear weight - it means the test substance did not cause irritation of skin.

Comparison of Stimulation Indexes between treated groups and control group revealed that the test substance did not cause increase in radioisotope incorporation into the DNA of dividing lymphocytes.


Migrated from Short description of key information:
The Local Lymph Node Assay (LLNA) with radionuclides was used. The testing was conducted according to the EU Method B.42, Skin sensitization: Local Lymph Node Assay, Council Regulation (EC) No. 440/2008, published in O.J. L142, 2008.
GLP study

Justification for classification or non-classification

From the results of the LLNA study follows that the substance has no skin sensitising properties and therefore it is not classified as sensitizing substance.