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EC number: 814-155-4
CAS number: 13188-82-4
The test substance shows a skin sensitizing potential in the Murine
Local Lymph Node Assay.
3H-thymidine incorporation Stimulattion Index1
Cell Count Stimulation Index1
Lymph Node Weight Stimulatin Index1
Ear Weight Stimulation Index1
1% in MEK
5% in MEK
10% in MEK
mean of test group 1 (vehicle control)
statistical evaluations were performed using the WILCOXON-test ( # for p≤0.05,
The skin sensitizing potential of Laromer IPGA was assessed using the
radioactive Murine Local Lymph Node Assay. The assay simulates the
induction phase for skin sensitization in mice. It determines the
response of cells in the auricular lymph nodes to repeated application
of the test substance to the dorsal skin of the ears. Groups of 5 female
CBA/CaOlaHsd mice each were treated with 1%, 5% and 10% (w/w)
preparations of the test substance in MEK or with the vehicle alone.
Each test animal was treated with 25 μL per ear of the appropriate
test-substance preparation or the vehicle alone, applied to the dorsal
surfaces of both ears on three consecutive days. Three days after the
last application, 20 μCi 3H-thymidine in 250 μL sterile saline were
injected into the tail vein of the mice. About 5 hours after the
3H-thymidine injection, the mice were sacrificed and the auricular lymph
nodes were removed. No signs of systemic toxicity were noticed in all
animals during general observation. The test-substance concentrations
did not cause increases (SI ≥ 1.25) in ear weights demonstrating the
absence of relevant ear skin irritation. The threshold concentration for
sensitization induction was >5% <10%. The EC 3 (estimated concentration
that leads to the SI of 3.0) for 3H-thymidine incorporation and the EC
1.5 (estimated concentration that leads to the SI of 1.5) for cell count
was calculated by linear regression from the results of these
concentrations to be 6.2% and 5.3%, respectively. Thus, it is concluded
that Laromer IPGA exhibits a skin sensitizing potential in the Murine
Local Lymph Node Assay under the test conditions chosen.
on the results of the skin sensitization testing, the test item is
classified as skin sensitization cat. 1B (H317) according to Regulation
(EC) No 1272/2008 (CLP).
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