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EC number: 203-825-6
CAS number: 111-01-3
Mean number of Proliferating Cells in the Lymph Nodes of each treatment
Ear thickness (mm)
Simulation index results:
Naive group : SI = 1.0 ± 0.5 Vehicule control group : SI = 1.0 ± 0.5
Positive control group : SI = 19.5 ± 7.1 25% studied squalane group : SI
= 2.1 ± 0.6 50% studied squalane group : SI = 2.8 ± 0.3 100% studied
squalane group : SI = 2.8 ± 1.3 100% commercial squalane : SI = 2.3 ± 0.7
The LLNA assay was conducted with seven separate groups of healthy
female mice (5 animals per group). Three groups were treated with
increasing concentrations of the test article (25, 50 and 100% squalane
in propylene glycol). A vehicule control group was treated with
propylene glycol and another group was treated with the positive control
(25% HCA in propylene glycol). An additionnal control (commercial
squalane) was supplied by the sponsor as a verification of similar
toxicological response from a substance analogous to the test article
but obtained from a different manufacturing procee. The naive control
group was sham-treated to provide baseline value. The test article
solutions, vehicule control and positive control were administratde by
topical application to the dorsum of each ear, once daily for three
The mice were given an intraperitoneal injection of thymidine analog 5
-bromo-2'-deoxy-uridine (BrdU) five days following the initial dose and
five hours prior to the sacrifice. At sacrifice the aurocular lymph
nodes were isolated, single cell suspensions of lymph node cells (LNC)
were generated and the LNC suspensions were analyzed by flow cytometry
for BrdU incorporation and the total LNC. The amount of proliferation
was determined as a measure of proliferation response of the local lymph
node. The stimulation index (SI) was calculated by dividing the
proliferative response of each test article treated aniaml by the mean
proliferative response of the vehicule control group, or, for the 100%
test article and 100% commercial squalane group, by the mean
proliferative response of the naive group. The mean SI ± standard
deviation was calculated for each group.Test article groups taht yielded
an SI > 3 were characterized as sensitizing substances.
The SI of the positive control group was 19.5. The group SI values for
the test article at 25, 50 and 100% were 2.1, 2.8 and 2.8 respectively.
The group SI value for the commercial squalane was 2.3.
Topical application of the test article squalane at 25, 50 and 100% in
propylene glycol resulted in SI values less than 3. Therefore, tis test
article is not a dermal sensitizer in the Local Lymph Node Assay.
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