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EC number: -
CAS number: -
In a local lymph node assay performed according to OECD Guideline 429 and in compliance with GLP, three groups of CBA/J (CBA/J@Rj) strain mice (4 females/dose) were treated for three consecutive days (D1, D2, D3) with 50 μL (25 μL per ear) of the test item at concentrations of 10%, 25% and 50% (v/v) in Acetone/Olive oil (4:1). A further group of four animals was treated with Acetone/Olive oil (4:1). At D6, the proliferation of lymphocytes in the draining auricular lymph nodes was determined by cell counting. The test concentrations for the main study were determined from a preliminary study tested at 100 %. Based on the results of preliminary study, the dose levels selected for the main test were 10%, 25% and 50% (v/v) in Acetone/Olive oil (4:1).
No mortality and no signs of systemic toxicity were noted in the test and controls animals during the test. Slight dryness was registered on D6 in the treated group at 25%. Slight dryness to dryness was registered on D5 and D6 in the treated group at 50%. An increase in ear thickness (+15.2%) was recorded at 50% and an increase in ear weight (+10.8%, + 12.8%, +56.4%) was recorded at respectively 10%, 25% and 50%. Therefore, the test item must be considered "slightly irritant" at the concentration of 50% and "non-irritant" at the concentrations of 10% and 25%. A stimulation index of more than 1.4 was recorded for two concentrations of the test item (25% and 50% (v/v) in acetone/olive oil). The Stimulation Index (SI) calculated by pooled approach was respectively 1.38, 2.13 and 3.81 for the treated group at 10%, 25% and 50%. The EC1.4 value determined by linear interpolation of points on the dose-response curve was 10.4%.
Under these experimental conditions, the test item must be classified in category 1B according to the annex I of the Regulation (EC) No. 1272/2008 and to the GHS.
This study is considered as acceptable and satisfies the requirement for skin sensitisation endpoint.
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