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EC number: -
CAS number: -
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
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.
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.
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.
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