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EC number: 217-461-0
CAS number: 1860-26-0
The test substance did not show a skin
sensitizing potential in the LLNA.
- not sensitizing in CBA/CaOlaHsd mice, according to OECD TG 429
Table 1: Results of the group findings for
Test item concentration % (w/v)
Number of lymph nodes
DPM per lymph nodeb)
Background (1 ml 5% trichloroacetic acid) in duplicate
a) = The
mean value was taken from the figures BG I and BG II.
the lymph nodes of the animals of a dose group were pooled, DPM/node was
determined by dividing the measured value by the number of lymph nodes
Table 2: Lymph node weight data
Lymph Node Weights after Necropsy
Lymph Node Weight (mg per animal)
Mean Lymph Node Weight (mg per group)
statistically significant increase vs. control group (p<0.001); SD=
3: Ear weight data
Ear Weights after Necropsy (mg per animal)
1 (pre-test 1)
2 (pre-test 1)
1 (pre-test 2)
2 (pre-test 2)
skin sensitising potential of the test substance was investigated in a
Local Lymphnode Assay conducted according to OECD guideline 429 and GLP
regulations by Harlan Cytotest Cell Research GmbH. The substance was
dissolved in acetone:olive oil (4+1). In the main experiment, three
groups each of four female mice were treated with 5, 10 or 20% (w/v)
test item concentration by topical application at the dorsum of each ear
on three consecutive days. A control group of four mice was treated with
the vehicle only. Five days after the first topical application, the
mice were intravenously injected into a tail vein with radio-labelled
thymidine (3H-methyl thymidine). Approximately five hours
after intravenous injection, the mice were sacrificed, the draining
auricular lymph nodes excised, pooled per animal and immediately
weighed. Furthermore, the ears were punched after sacrifice at the
apical area using a biopsy punch and were immediately pooled per animal
and weighed using an analytical balance. Single cell suspensions of
lymph node cells (pooled per group) were prepared and lymphocyte
proliferation was quantified by measuring the incorporation of
radio-labelled thymidine into the lymph node cells by beta-Scintillation
animals did not show any signs of systemic toxicity during the course of
the study and no cases of mortality were observed. Signs of local
irritation (e.g. reddening of the ear skin, ear swelling) were also not
observed during the study period.
Indices (S.I.) of 0.72, 0.84, and 2.91 were determined with the test
item at concentrations of 5, 10, and 20% in acetone:olive oil (4+1),
respectively. A statistically significant increase in lymph node weights
was observed in the group treated with 20% test item concentration in
comparison to the vehicle control group (p<0.001), however, this is not
considered as biologically relevant as none of the S.I.s determined for
the tested concentrations exceeded the threshold of 3. A statistically
significant increase in ear weights was also observed in this group in
comparison to the vehicle control group (p=0.009) indicating the
irritation potential of the test item.
test substance did not show a skin sensitizing potential in this assay
under the conditions of this study.
The available experimental test data are
reliable and suitable for classification purposes under Regulation
1272/2008, as amended for the thirteenth time in Regulation (EU) No
2018/1480.. As a result the substance is not considered to be classified
for skin sensitization under Regulation (EC) No. 1272/2008.
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