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EC number: 616-105-5 | CAS number: 74504-65-7
A slight dryness was registred at D6 in thre treated groups at 50% and 100%.
A moderate to important increase in ear thickness (+16.5%, +29.4%, +41.7%) and in ear weight (+18%, +42.5%, +19.5%) was recorded respectively at the concentrations of 25%, 50% and 100%. The test item must therefore be considered as slightly irritant at 25% and 50% and irritant at 100%.
The test was performed to access the skin sensitisation potential of the test item, Dermosoft DGCM.., in the CBA/J mouse strain following topical applications to the dorsal surface of the ear. The test was performed according to OECD guideline 429.
Three groups of each four animals, were treated for three consecutive days with 50 ul (25 ul per ear) with the undilited test item and the test item as a solution in acetone(olive oil (4:1) at concentrations of 25% and 50% (v/v). A further group of four animals was treated with acetone/olive oil (4:1) alone.
No mortality and no signs of systemic toxicity were noted in the test and the control animals during the test.
A slight dryness was registred at D6 in thre treated groups at 50% and 100%. A moderate to important increase in ear thickness (+16.5%, +29.4%, +41.7%) and in ear weight (+18%, +42.5%, +19.5%) was recorded respectively at the concentrations of 25%, 50% and 100%. The test item must therefore be considered as slightly irritant at 25% and 50% and irritant at 100%.
The SI calculated by pooled approach was 1.71, 2.76 and 3.17, for the treated groups at 25%, 50% and 100%, respectively.
In view of these results, under these experimental conditions, the itest item, Dermosoft DGMC.., must be classified in category 1B "skin sensitisation" according to the Globally Harmonized System (COM (2007)355 final). The signal word "warning" and the hazard statement H317 "may cause an allergic reaction" are required.
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