Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In the study, 3 female mice per group received 3 consecutive applications (day 0 – day 2) to the same application site of 3%, 10% and 30% w/w (25 µl) preparations of the test substance in propylene glycol by epicutaneous application (simulating dermal contact with the compound which is possible to occur under practical use conditions; dorsal part of both ears).

On study day five (about 66 to 72 hours after the last application of test substance to the ears) the mice were injected intravenously with 20 μCi of 3H-thymidine in 250 μl of sterile saline into the tail vein.

The animals were sacrificed on study day 5 about 5 hours after 3H-thymidine injection by cervical dislocation. The ear and lymph node weights were then determined. The thymidine incorporation was also determined as well as cell count.

Based on the 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), the concentration dependent increase in lymph node weights as well, and the concomitant concentration dependent increase of 3H-thymidine incorporation into the cells (and biologically relevant; increase above the cut off stimulation index of 3), it is concluded that Gelb LD 6259 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%. 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 semi-logarithmical regression from the results of all concentrations to be 2.2% and 1.8%, respectively.


Migrated from Short description of key information:
Only one local lymph node assay (BASF, 2009; Report No. 58H0646/082177) performed according to the OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay) is available. It is conluded that Gelb LD 6259 shows a skin sensitizing effect in the Murine Local Lymph Node Assay under the test conditions chosen.

Justification for classification or non-classification