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EC number: 942-426-8 | CAS number: -
LLNA: Skin sensitiser (OECD 429, GLP, K, Rel. 1)
A study was performed to assess the skin sensitisation potential of test material in the CBA/Ca (CBA/CaOlaHsd) strain mouse following topical application to the dorsal surface of the ear. The method was conducted according to the OECD test guideline No 429 and in compliance with GLP.
Following a preliminary screening test in which no clinical signs of toxicity were noted at the concentration (undiluted, 100 %), 100 % was selected as the highest dose to be investigated in the main test.
Three groups, each of five animals, were treated with 50 μl (25 μl per ear) of test material as a solution in acetone/olive oil 4:1 at concentrations of 100 %, 50 % or 25 % v/v for 3 consecutive days. A further group of five animals was treated with acetone/olive oil 4:1 alone. The animals were allowed to rest without dosing on days 4 and 5. On day 6, the proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of 3H-Methyl Thymidine.
The irritant potential of the test item was assessed in parallel by measurement of ear thickness on days 1 to 6.
The Stimulation Index values expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
The concentration of test material expected to cause a 3 fold increase in 3HTdR incorporation (EC3 value) was calculated to be 22 %.
The historical positive control, α-Hexylcinnamaldehyde, gave a SI of 8.42, when tested at 25 % v/v. The test system was therefore considered to be valid.
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. No visual local skin irritation or excessive irritation indicated by an equal to or greater than 25% increase in mean ear thickness were noted at any dose concentration evaluated. Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.
Under the test conditions, test material is classified as a skin sensitiser Category 1B in the Local Lymph Node Assay according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for sensitisation endpoint.
A key study was identified on the substance (Harlan, 2014). In a Local Lymph Node Assay (LLNA) performed according to the OECD test guideline No 429 and in compliance with GLP, groups of mice were treated with the test item undiluted (100%) or as a solution in acetone/olive oil 4:1 at concentrations of 50% or 25% v/v. The irritant potential of the test item was assessed in parallel by measurement of ear thickness on days 1 to 6.
The Stimulation Index values were 3.31, 5.31 and 10.12 for the concentrations of 25%, 50% and 100%, respectively.
The concentration of the source substance expected to cause a 3 fold increase in 3HTdR incorporation (EC3 value) was calculated to be 22 %.
Under the test conditions, the source substance is classified as a skin sensitiser.
The substance has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP).
Based on the available data, the substance is classified as Skin Sens. 1B, H317 (May cause an allergic skin reaction) according to the CLP and to the GHS as the EC3 is > 2%.
No data was available regarding respiratory sensitisation.
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