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EC number: 701-326-2 | CAS number: -
A study was performed to assess the skin sensitisation potential of ST 10 C 08 in the CBA/Ca 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 maximum attainable concentration (10%), ST 10 C 08 concentration of 10% 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 ST 10 C 08 as a solution in acetone/olive oil 4:1 at concentrations of 10%, 5% or 2.5% 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:
Test / Control Ratio
The historical positive control, α-Hexylcinnamaldehyde, gave a SI of 6.29, 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, ST 10 C 08 is not classified as a skin sensitiser 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.
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