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EC number: 300-723-4
CAS number: 127823-21-6
Table 1 Main
Size Lymph Nodes, Radioactivity Counts (DPM) and Stimulation Index (SI)
DPM ± SEM4
SI ± SEM
1 TS = test item (% w/w).
2 Relative size auricular lymph nodes (-,
-- or ---: degree of reduction, +,++ or +++: degree of enlargement, n:
considered to be normal).
Disintegrations per minute.
4 SEM = Standard
Error of the Mean.
5 Value not used
for interpretation as this value was considered an outlier based on the
Dixon’s Q-test. There
were no other values identified as outliers within this study.
The objective of this study was to evaluate whether Tricyclodecanemonomethylol
acrylate induces skin sensitization in mice after three epidermal
exposures of the animals under the conditions described in this study
plan (TG OECD 429).
Test item concentrations selected for the main study were based on
the results of a pre-screen test. At a 100%, 50%, 25% and 10% test item
concentration, variation in ear thickness during the observation period
were more than 25% from Day 1 pre-dose values and/or clinical signs of
systemic toxicity were noted. Therefore these concentrations did not
meet the selection criteria. At a 5% and 2% test item concentration, no
signs of systemic toxicity were noted and no to very slight irritation
were observed and therefore the 5% concentration was selected as highest
concentration for the main study.
In the main study, three experimental groups of five female CBA/J
mice were treated with test item concentrations of 1, 2 or 5% w/w on
three consecutive days, by open application on the ears. Five vehicle
control animals were similarly treated, but with the vehicle alone
(Acetone/Olive oil (4:1 v/v)). Three days after the last exposure, all
animals were injected with 3H-methyl thymidine and after five hours the
draining (auricular) lymph nodes were excised and pooled for each
animal. After precipitating the DNA of the lymph node cells,
radioactivity measurements were performed. The activity was expressed as
the number of disintegrations per minute (DPM) and a stimulation index
(SI) was subsequently calculated for each group.
No irritation was observed in any of the animals. No mortality
occurred and no clinical signs of systemic toxicity were observed in the
animals of the main study. Body weights and body weight gain of
experimental animals remained in the same range as controls over the
study period. The majority of auricular lymph nodes were considered
normal in size, except for the nodes in one animal treated at 1%, two
animals treated at 2% and four animals treated at 5%, which were
considered to be enlarged. No macroscopic abnormalities of the
surrounding area were noted for any of the animals.
Mean DPM/animal values for the experimental groups treated with
test item concentrations 1, 2 and 5% were 623, 590 and 1118 DPM,
respectively. The mean DPM/animal value for the vehicle control group
was 378 DPM. The SI values calculated for the test item concentrations
1, 2 and 5% were 1.6, 1.6 and 3.0, respectively. These results indicate
that the test item could elicit a SI = 3. The data showed a
dose-response and an EC3 value (the estimated test item concentration
that will give a SI =3) of 5% was determined.
The six-month reliability check with Alpha-hexylcinnamaldehyde
indicates that the Local Lymph Node Assay as performed at Charles River
Den Bosch is an appropriate model for testing for contact
The results of an LLNA study, performed according to OECD guideline 429
and GLP principles, indicate that Tricyclodecanemonomethylol acrylate
could elicit a SI = 3. An EC3 value of 5% was determined. Based on these
results, the test substance is classified as Category 1B for skin
sensitising properties according to GHS and Regulation (EC) 1272/2008.
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