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EC number: 947-570-5
CAS number: -
Observations and Mortality Data
were no deaths. No
signs of systemic toxicity were noted in the test or control animals
during the test.
weight change of the test animals between Day 1 and Day 6 were
comparable to that observed in the corresponding control group animals
over the same period.
A moderate (+15.2%) to important (+41.6%)
increase in ear thickness was recorded respectively at the concentration
of 50% and 100%. An important increase in ear weight (+60.3%) was
recorded at the concentration of 100%.
Stimulation Index (SI) of 2.22 was recorded for the positive control
diluted at 25 % in the vehicle.
SI result was more than 1.4 as expected.
A study was performed to assess the skin sensitisation potential
of test material in the CBA/Ca (CBA/J) 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 a concentration of 10% w/w, this concentration
was selected as the highest dose investigated in the main test of the
Local Lymph Node Assay. Three groups, each of four animals, were treated
with 50 µL (25 µL per ear) of the test item as a solution in
acetone/olive oil 4:1 at concentrations of 10%, 5% or 25% w/w. A further
group of four animals was treated with acetone/olive oil 4:1 alone.
The Stimulation Index (SI) was calculated from the formula SI =
cell count of treated group / cell count of control group.
The historical positive control, α-Hexylcinnamaldehyde, gave a SI
of 2.22, when tested at 25 % v/v. The test system was therefore
considered to be more sensitive than planed (2.22 instead of 1.4).
There were no deaths. No signs of systemic toxicity were noted in
the test or control animals during the test. Body weight change of the
test animals between Day 1 and Day 6 were comparable to that observed in
the corresponding control group animals over the same period.
Under the test conditions, test material should not be classified
as a skin sensitiser according to the annex VI of the Regulation EC No.
1272/2008 (CLP) .
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