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EC number: 268-820-3 | CAS number: 68140-98-7
The aim of this study was to determine the skin sensitization potential of 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol following dermal exposure in the Local Lymph Node Assay in mice. The pooled treatment group approach was used in this test.
The maximum dose selection was performed according to the relevant guidelines and based on results of a formulation evaluation and two consecutive Dose Range Finding tests (DRFs).
The liquid test item was adequately miscible in Acetone : Olive oil 4:1 (v/v) mixture (AOO) or N,N-Dimethylformamide (DMF). Formulations prepared with both vehicles were evaluated in the DRFs to find the most adequate vehicle and the highest applicable concentration. Symptoms of adverse effects were observed in both vehicles at high test concentrations (irritation in AOO, irritation and systemic toxicity in DMF) in the DRFs. Based on the results AOO was more adequate vehicle than DMF and the highest applicable non-toxic, non-irritant concentration was 10 % (w/v) in AOO. According to this the test item was examined in the main test as 10 %, 5 %, 2.5 % and 1 % (w/v) formulations in AOO.
Appropriate positive control (α-Hexylcinnamaldehyde, HCA) and a negative control group dosed with the vehicle of both the positive control and the test item (AOO) were employed.
The positive control item (25 % (w/v) HCA in AOO) induced significant stimulation over the relevant control (SI = 20.9). Thus, confirming the sensitivity and validity of the assay.
No mortality was observed during the main test. No significant, treatment related effect on body weights or any other sign of systemic toxicity were observed in any treatment group. No signs of irritation (monitored by erythema scoring) or any other local effect were observed at the treatment site (ears) in any treatment group.
Significantly increased lymphoproliferation (indicated by an SI ≥ 3) compared to the control was noted for 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol at the applied test concentrations. Significant dose-response correlation was observed. The observed stimulation index values were 20.4, 12.0, 4.6 and 4.1 at test item concentrations of 10 %, 5 %, 2.5 % and 1 % (w/v), respectively. Significant dose-response correlation was observed (p = 0.01, r = 0.99, evaluated by linear regression using the SI values).
According to evaluation criteria of the relevant guidelines, the significantly increased lymphoproliferation (indicated by an SI ≥ 3) at the maximum feasible concentration of 10 % (w/v) and also at lower concentrations as well as the significant dose-response correlation are considered as evidence that 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol is a skin sensitizer.
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