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EC number: 470-080-3
CAS number: -
There is a reliable study available to
assess the skin sensitising potential of the test substance.
In a LLNA skin sensitisation test according
to OECD guideline 429 (Calvert Lab. 2006), groups of 5 CBNJ female mice
were treated on the dorsal surface of both ears once per day for 3 days
with 0.1 %, 1 %, 5% or 10% (w/v) of the test substance, with the vehicle
(DMSO), with the vehicle for the positive control (acetone/olive oil,
4:1), or with the positive control (HCA at 35%). On Day 6, the mice were
injected iv with 20 µCi of 3H-thymidine in sterile saline. Five hours
later, the mice were euthanized and the draining auricular lymph nodes
were removed. The lymph node cells were precipitated with 5%
trichloroacetic acid (TCA) and the pellets counted in a
beta-scintillation counter to determine incorporation of the 3-thymidine.
A test material is considered to have skin
sensitizing activity if, at one or more concentrations, it induces a
3-fold or greater increase in proliferative activity relative to the
concurrent vehicle treated control.
There was no mortality and all animals
appeared normal throughout the study. The application sites on the mice
from the positive control group appeared wet on Days 2-4. The positive
vehicle control animals also exhibiting wet ears on Day 4. There were no
other findings. At termination, the lymph nodes of the mice treated with
the positive control were enlarged relative to the lymph nodes from the
positive control vehicle treated mice but otherwise appeared normal. The
lymph nodes from the mice in the vehicle treated groups and all the test
article treated groups were normal in size and appearance. Mean body
weights at Day 1 and Day 6 and mean changes in body weights were
evaluated. There were no statistically significant differences observed
between any of the treatment groups. Therefore, the test articles did
not appear to cause any overt toxicity. The positive control, 35% (vfv)
HCA, resulted in a stimulation index (SI) of 5.1 indicating a positive
response. This response was also statistically significant when compared
to the A00 vehicle control group (p = 0.0001). Exposure to the test
substance at 0.1 %, 1.0%, 5% or 10% (w/v) resulted in stimulation
indices of 1.25, 1.17, 1.96 and 1.64, respectively. No statistically
significant differences were found between the groups treated with the
test substance at 0.1%, 1.0 % or 10% (w/v) and the DMSO vehicle control.
A statistically significant difference was found between the 5.0% (w/v)
group and the DMSO vehicle control (p = 0.0343). However, given the low
stimulation index and the absence of any dose response, this difference
is not considered meaningful.
Treatment with the test substance up to did
not resulted in stimulation indices of 3 or greater, indicating a
Under our experimental conditions, the test
did not induce delayed contact hypersensitivity in the murine Local
Lymph Node Assay.
No data available.
Based on the available LLNA study, there is
no indication for a relevant skin sensitising potential of the test
substance. Thus, no classification is warranted according to 67/548/EEC and
Regulation (EC) No 1272/2008 (GHS, CLP), respectively.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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