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EC number: 211-989-5
CAS number: 732-26-3
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
study has been assigned a reliability score of 1 in line with the
principles for assessing data quality as defined by Klimisch et al.
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.
In accordance with the criteria for classification as defined in Annex
I, Regulation (EC) No 1272/2008, the substance requires classification
with respect to skin sensitisation as Category 1B (H317: May cause an
allergic skin reaction).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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