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EC number: 203-596-2
CAS number: 108-58-7
Three experimental groups of five female CBA/J mice were treated with
test item concentrations of 25, 50 or 100% 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
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. Scaliness, noted for
three animals, was considered not to have a toxicologically significant
effect on the activity of the nodes.
The auricular lymph nodes of the animals of the control animals, animals
treated at 25% and most animals treated at 50% were considered normal in
size. The lymph nodes of the animals treated at
100% and two animals treated at 50% were considered enlarged. No
macroscopic abnormalities of the surrounding area were noted for any of
Mean DPM/animal values for the experimental groups treated with test
item concentrations 25, 50 and 100% were 2969, 6377 and 8516 DPM,
respectively. The mean DPM/animal value for the vehicle control group
was 706 DPM. The SI values calculated for the test item concentrations
25, 50 and 100% were 4.2, 9.0 and 12.1, respectively.
These results show that the test substance elicits a SI ≥ 3. Although,
the data do not permit the use of linear interpolation, calculation of
EC3 values (the estimated test substance concentration that will give a
SI =3) by loglinear extrapolation can provide a reliable estimation of
sensitization potency class for use in risk assessment and can avoid the
need for repeat animal testing. The data show a clear dose response and
a slope ratio of 0.32 was calculated indicating that extrapolation can
provide a reliable estimation of the EC3 value according to Ryan et al
2007. An estimated EC3 value of 21.0% was calculated.
The six-month reliability check with Alpha-hexylcinnamaldehyde indicates
that the Local Lymph Node Assay as performed at WIL Research Europe is
an appropriate model for testing for contact
According to the Regulation (EC) No 1272/2008 on classification,
labelling and packaging of items and mixtures (including all
amendments), Resorcinol diacetate should be classified as skin
sensitizer (Category 1B) and labeled as H317: May cause an allergic skin
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