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EC number: 211-989-5
CAS number: 732-26-3
No irritation and no signs of systemic toxicity were
observed in any of the animals examined. White staining of test material
remnants on the dorsal surface of the ears of all animals on Days 2 and
3 did not hamper scoring for erythema.
Variations in ear thickness during the observation period
were less than 25 % from Day 1 pre-dose values.
Skin reactions / Irritation
No irritation of the ears was observed in any of the
animals examined. White staining of test material remnants on the dorsal
surface of the ears of one animal treated at 10 % and all animals
treated at 25 and 50 % did not hamper scoring for erythema.
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.
Macroscopy of the auricular lymph nodes and
All auricular lymph nodes of the animals of the 10 % and
control groups were considered normal in size. The auricular lymph nodes
of two animals treated at 25 % and all animals treated at 50 % appeared
larger in size.
No macroscopic abnormalities of the surrounding area were
noted for any of the animals.
Table 1: Relative size of lymph nodes, radioactivity
counts (DPM) and Stimulation Index (SI)
Test material (% w/w)
Mean DPM ± SEM³
Mean SI ± SEM
692 ± 132
1.0 ± 0.3
1155 ± 146
1.7 ± 0.4
2289 ± 388
3.3 ± 0.8
3174 ± 576
4.6 ± 1.2
*Relative size auricular lymph nodes (+,++ or +++: degree
of enlargement, n: considered to be normal)
¹DPM = Disintegrations per minute
³SEM = Standard Error of the Mean
An assessment of the potential for the test material to cause skin
sensitisation was made in the mouse in a Local Lymph Node Assay (LLNA)
study carried out in accordance with the standardised guidelines OECD
429, EU Method B.42 and US EPA OPPTS 870.2600 under GLP conditions.
The test material concentrations selected for the main study were based
on the results of a pre-screen test. In the main study, three
experimental groups of five female CBA/J mice were treated with test
material concentrations of 10, 25 or 50 % w/w on three consecutive days,
by open application on the ears. Five vehicle control animals were
similarly treated, but with vehicle alone (N,N-Dimethyl formamide).
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 of the ears was observed in any of the animals examined.
White staining of test material remnants on the dorsal surface of the
ears of one animal treated at 10 % and all animals treated at 25 and 50
% did not hamper scoring for erythema.
All auricular lymph nodes of the animals of the 10 % and control groups
were considered normal in size. The auricular lymph nodes of two animals
treated at 25 % and all animals treated at 50 % appeared larger in size.
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
material concentrations 10, 25 and 50 % were 1155, 2289 and 3174 DPM,
respectively. The mean DPM/animal value for the vehicle control group
was 692 DPM. The SI values calculated for the material concentrations
10, 25 and 50 % were 1.7, 3.3 and 4.6, respectively.
These results indicate that the test material could elicit a SI ≥ 3. The
data showed a dose-response and an EC3 value (the estimated test
material concentration that will give a SI =3) of 22.2 % was calculated.
Under the conditions of this study, the test material is considered to
be a sensitiser.
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