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EC number: 218-212-9
CAS number: 2082-59-9
The test item was assessed for both its skin sensitizing and irritant
potential in a modified Local Lymph Node Assay with the following
concentrations: 0 % (vehicle control), 2 %, 20 % and 100 %.
The test item was formulated in acetone / olive oil 4:1 to yield a
solution. Compared to vehicle (A/OO) treated animals there were
increases regarding the cell counts and the weights of the draining
lymph nodes in all dose groups, which are of statistical significance.
In addition, the "positive level" of the stimulation index for the cell
counts, which is 1.4, was exceeded in all dose groups. The “positive
level”, indicating irritating potential of the test item, which is 1.10
for ear swelling index, was statistically significantly exceeded in the
high dose group. Therefore, an indication for a specific skin
sensitizing effect after administration of a concentration >= 2 % test
item is revealed in this test system, and also an indication for an
unspecific irritant potential of the undiluted test item. Although it is
not possible to calculate an exact EC value from the data obtained, it
can be assumed that the EC value is in any case below 1%. In accordance
with the classification proposed in the Technical Report No. 87 of the
ECETOC this value corresponds to a strong skin sensitizer. The validity
of the assay was demonstrated by the positive results of the positive
control group (40 % Alpha Hexyl Cinnamic Aldehyde).
Table 1: Summary of the LLNA/IMDS results (means of 6 animals per group)
Dose 2 %
Dose 20 %
Dose 100 %
weight of draining lymph nodes
cell count in draining lymph nodes
Ear swelling in 0.01 mm on day 4 (index)
Ear weight in mg / 8 mm diameter punch on day 4 (index)
* statistically significant increase (p <= 0.05)
Test item - sensitizing potential: The NMRI mice did show
an increase in stimulation indices for cell counts, which is of
statistical significance (see Table1), and for weights of the draining
lymph nodes after application of the test item at 2 %, 20 % and 100 %.
In addition, the "positive level", which is 1.4 for cell count indices,
was exceeded in these groups ( (value group 2%: 2.00; value group
20%: 3.83; value group 100%: 4.02).
Test item - irritating potential: The “positive level”,
indicating irritating potential of the test item, which is 1.10 for ear
swelling index was statistically significantly exceeded in the high dose
group (value: 1.27). In the low and mid dose group the ear swelling are
statistical significant increased. A significant increase compared to
vehicle treated animals regarding ear weights was detected in the mid
and high dose group.
Positive control - sensitizing potential: After treatment with
Alpha Hexyl Cinnamic Aldehyde (Positive Control) the NMRI mice showed
statistically significant increases in the weights of the draining lymph
nodes and in the stimulation indices for cell counts (see Table 1)
compared to vehicle control animals. The "positive level", which is 1.4
for cell count indices, clearly was exceeded (value: 2.23).
Positive control - irritating potential: The "positive level" of
ear swelling, which is 1.10 for ear swelling index, was exceeded in the
positive control group. This increase was of statistical significance. A
significant increase compared to vehicle treated animals regarding ear
weights was also detected. The body weights of the animals were not
affected by any of the treatment.
According to Regulation (EC) No 1272/2008, Annex I the test item shall
be classified as skin sensitiser (Category 1A)
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