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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
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
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.
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.
study is considered as acceptable and satisfies the requirement for
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