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:

Procedure and observations

The substance was tested for the assessment of skin sensitisation potential with the murine local lymph node assay with radionuclides in mice. Five mice per group were exposed on the dorsum of both ears once a day by test substance (0.2, 2, 20%) and control substances during 3 consecutive days. Primary proliferation of lymphocytes in the lymph node was evaluated and the SI determined. The animals exposed to the test substance at all concentrations showed no pathological skin reactions and no other negative clinical symptoms of intoxication. Comparison of Stimulation Indexes (SI) between all treated groups and control vehicle group revealed that the test substance did not cause significant increase in radioisotope incorporation into the DNA of dividing lymphocytes.

Discussion

Thus, the test item is not considered to be a skin sensitizer.


Migrated from Short description of key information:
The skin sensitizing potential of the test item was assessed in a murine local lymph node assay in mice (OECD 429, GLP). 0.2, 2 and 20% solution was applied onto the dorsum of both ears for three consecutive days. The test item did not cause clinical symptoms and the SI of all treatment groups was below 3. Therefore, the substance is not considered to be a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC,as amended for the 30th time in Directive 2008/58/EC.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).