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 local lymph node assay with Biofert Plusz was performed according to OECD Guideline 429 (adopted in 2002). The test item was suspended in propylene glycol at concentrations of 25, 50 and 100% of the original liquid substance (7.03, 14.05, or 28.1 dry mass respectively). The animals did not show any clinical signs or influence on body weight.

The proliferative capacity of pooled lymph nodes was determined by the incorporation of 3H-methyl thymidine. A test item is regarded as a sensitiser if the exposure resulted in a 3 -fold or greater increase in incorporation of 3H-methyl thymidine as compared to the ontrol (as indicated by the stimulation index).

Stimulation indices (SI) of 1.99, 2.18 and 1.47 were determined for the three dose levels tested. The EC3 value could not be calculated, since none of the tested concentrations induced an SI greater than 3. Consequently, Biofert Plusz is not a skin sensitiser in this test system.

Migrated from Short description of key information:
No skin sensitising properties were detected in the mouse local lymphnode assay.

Justification for classification or non-classification