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EC number: 947-716-8
CAS number: -
skin sensitising potential of the test substance was investigated in a
Local Lymph Node Assay (LLNA) in female CBA/N mice using BrdU-ELISA
method according to OECD Guideline 442B and in compliance with GLP
(2017). A preliminary range-finding study was performed at dose levels
of 5, 10, 25, 50 and 100% to determine the appropriate dose levels of
the test substance in acetone/olive oil 4:1 (v/v). Based on the result
of the dose range finding study, the high dose for the main study was
selected at 100%. Two additional low dose levels (25 and 50%) were added
for the first main experiment (Set 1). In a second experiment (Set 2)
doses of 1, 5 and 10% were used. In addition, positive and negative
controls were included. 5 animals per test group, negative and positive
control group were used. In the main study, the test substance was
applied to the dorsum of each ear for 3 consecutive days. All animals
were observed for mortality, clinical signs and erythema for 6 days.
Body weights were recorded on Day 1 prior to dosing and on Day 6. Ear
thickness was measured on Day 1, 3 and 6. After necropsy on day 6 ear
weights and stimulation indices were measured. In the test substance
groups at dose levels of 25, 50 and 100% (Set 1) the body weight was not
significantly increased when compared to the negative control group. The
erythema score, ear weights, ear thickness and stimulation index were
significantly increased when compared to the negative control group. In
the test substance groups at 1, 5 and 10% the body weight and the
stimulation indices were not significantly increased when compared to
the negative control. Erythema score, ear weights and ear thickness were
significantly increased when compared to the negative control. No
abnormalities in clinical signs or death were observed in any animal.
The test substance produced a stimulation index of ≥ 1.6 in three
concentrations of 25, 50 and 100% (w/v) and an EC1.6 value of 12.73% was
calculated. Based on the results of this LLNA, the test substance was
classified as Skin Sens. 1B.
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