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EC number: -
CAS number: -
See the attached document for information on
tables of results
A study was performed to assess the skin
sensitisation potential of test material in the CBA/Ca (CBA/CaOlaHsd)
strain mouse following topical application to the dorsal surface of the
ear. The method was conducted according to the OECD test guideline No
429 and in compliance with GLP. Following a preliminary screening test
in a single animal in which no clinical signs of systemic toxicity or
excessive local skin irritation were noted at a concentration of 100%,
this concentration was selected as the highest dose investigated in the
main test of the Local Lymph Node Assay. A group of five animals was
treated with 50 μL (25 μL per ear) of the undiluted test item. A further
group of five control animals were untreated. Due to mortality in the
initial main test, an additional group of animals was treated with 50 μL
(25 μL per ear) of the test item as a solution in acetone/olive oil 4:1
at a concentration of 50% v/v. A further group of five control animals
was treated with acetone/olive oil 4:1 alone. The irritant potential of
the test item was assessed in parallel by measurement of ear thickness
on days 1 to 6. The Stimulation Index values expressed as the mean
radioactive incorporation for each treatment group divided by the mean
radioactive incorporation of the vehicle control group are as follows:
Test Item Treatment Group
Initial Test 100%
Additional Test 50% v/v in acetone/olive oil 4:1
The historical positive control,
α-Hexylcinnamaldehyde, gave a SI of 8.42, when tested at 25 % v/v. The
test system was therefore considered to be valid.
No systemic toxicity or excessive local skin
irritation were noted at a concentration of 50%, therefore this dose
level was considered to be of biological relevance to the endpoint of
Under the test conditions, test material is
classified as a skin sensitizer in the Local Lymph Node Assay according
to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and
satisfies the requirement for sensitisation endpoint.
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