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 dermal sensitisation of 400160 was tested in the local lymph node assay according to EU method B.42 in a GLP certified testing facility. 3 groups of young adult CBE/CaCrl mice (n=4/group, female) were treated daily with the test item at concentrations of 5, 10 and 25% (w/v) in acetone:olive oil (4:1 v/v) by topical application to the dorsum of each ear for 3 consecutive days. A control group of 4 mice was treated with the vehicle only. 5 days after the first topical application the mice were injected intravenously into a tail vein with 3HTdR. Approximately 5 h after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3HTdR measured in a β-scintillation counter.

As positive control α-hexylcinnamaldehyde in acetone:olive oil (4:1 v/v) was used. No signs of systemic toxicity were observed during the study period. On days 3 and 4, the animals treated with a test item concentration of 25% showed an erythema of the ear skin (Score 1). Animals treated with 5 or 10% test item concentration did not show any signs of local skin irritation. No deaths occurred during the study period.

Stimulation Indices (S.I.) of 1.30, 1.58, and 2.00 were determined with the test item at concentrations of 5, 10, and 25% (w/v) in acetone:olive oil (4:1 v/v), respectively. Although a dose response was observed, the test item 400160 was not a skin sensitizer as none of the Stimulation Indices exceeded the threshold value of 3.


Migrated from Short description of key information:
400160 was not a skin sensitizer at the tested concentrations of 5, 10, and 25% (w/v).

Justification for selection of skin sensitisation endpoint:
Only one study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the results of the LLNA test described above, 400160 does not meet the current EU-CLP criteria for classification as a skin sensitiser. No risk phrase is required.