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EC number: 237-864-5
CAS number: 14025-15-1
Table: Relative size lymph nodes, radioactivity counts (DPM) and
Stimulation Index (SI)
SI ± SEM
1. TS = test substance (% 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
The study was carried out based on the
guidelines described in: OECD, Section 4, Health Effects, No.429 (2010);
EC, No 440/2008; B42: "Skin Sensitization: Local Lymph Node Assay"; EPA,
OPPTS 870.2600 (2003) “Skin Sensitization”.
Test substance 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 substance
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 (1% watery pluronic L92). 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 theof 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/grey
test substance remnant were present on the dorsal surface of the ears of
all animals at 10, 25 and 50% on Days 1-3, and at 50% also on Day 4 for
one animal, which did not hamper scoring of skin reactions.
All auricular lymph nodes of the animals of
the experimental and control groups were considered normal in size. No
macroscopic abnormalities of the surrounding area were noted in any of
the animals. Mean DPM/animal values for the experimental groups treated
with test substance concentrations 10, 25 and 50% were 466, 571 and 612
DPM respectively. The mean DPM/animal value for the vehicle control
group was 513 DPM. The SI values calculated for the substance
concentrations 10, 25 and 50% were 0.9, 1.1 and 1.2 respectively. Since
there was no indication that the test substance elicited an SI≥3
when tested up to 50%, EDTA-CuNa2was considered to be a non
The six-month reliability check withAlpha-hexylcinnamicaldehyde
indicates that the Local Lymph Node Assay as performed at WIL Research
Europe is an appropriate model for testing for contact
Based on these results, EDTA-CuNa2 would not
be regarded as a skin sensitizer according to the recommendations made
in the test guidelines. The test substance does not have to be
classified and has no obligatory labelling requirement for sensitization
by skin contact according to the Globally Harmonized System of
Classification and Labelling of Chemicals (GHS) of the United Nations
(2011) and theRegulation (EC) No 1272/2008 on classification,
labelling and packaging of substances and mixtures.
EDTA-CuNa2 did not show skin sensitizing
properties in the murine LLNA.
Based on the knowledge that so far all known
respiratory sensitizers have also tested positive in a skin
sensitization test, it is not expected that EDTA-CuNa2 would show
respiratory sensitizing properties.
Based on the results of the LLNA, EDTA-CuNa2
does not need classification for skin sensitization.
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