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EC number: 627-083-1
CAS number: 244235-47-0
According to the result of an LLNA study (OECD 429) tested with a close
homologue (CAS-No. 174333 -80 -3) of
the registered substance, the registered substance
(CAS-No. 244235 -47 -0) is considered to be a skin sensitizer.
Viability / Mortality
No deaths occurred during the study period.
No symptoms of local toxicity at the ears of the animals and no systemic
observed during the study period.
The body weight of the animals, recorded prior to the first application
and prior to
treatment with 3HTdR, was within the range commonly recorded for animals
of this strain
The measured ear thickness of all animals treated was recorded prior to
the 1st application
and prior to necropsy. A statistically significant increase in ear
thickness was observed for
the animals treated with 10 and 25% test item concentration (p<0.001).
In order to study a possible contact allergenic potential of the test
substance, three groups
each of four female mice were treated daily with the test item at
concentrations of 10, 25,
and 50% (w/w) in acetone:olive oil (4+1) by topical application to the
dorsum of each ear
(left and right) for three consecutive days. A control group of four
mice was treated with
the vehicle (acetone:olive oil (4+1)) only. Five days after the first
topical application the
mice were injected intravenously into a tail vein with radio-labelled
thymidine). Approximately five hours after intravenous injection, the
mice were sacrificed,
the draining auricular lymph nodes excised and pooled per group. Single
of lymph node cells were prepared from pooled lymph nodes, which were
washed and incubated with trichloroacetic acid overnight. The
proliferative capacity of
pooled lymph node cells was determined by the incorporation of 3H-methyl
measured in a scintillation counter.
All treated animals survived the scheduled study period and no signs of
local irritation or
systemic toxicity were observed. A statistically significant increase in
ear thickness was
observed in the animals treated with 10 and 25% test item concentration
However, this was not seen in the animals treated with 50% test item
A test item is regarded as a sensitiser in the LLNA if the exposure to
one or more test
concentration resulted in 3-fold or greater increase in incorporation of
with concurrent controls, as indicated by the Stimulation Index (S.I.).
concentration of test item required to produce a S.I. of 3 is referred
to as the EC3 value.
In this study Stimulation Indices of 12.80, 16.10, and 15.74 were
determined with the test
item at concentrations of 10, 25, and 50% in acetone:olive oil (4+1).
The EC3 value could
not be calculated, since all obtained SI´s were above 3.
The skin sensitisation potential of the test substance was inverstigated
in a Local Lymph Node Assay. Three groups of four femal mice were
treated by topical application to the dorsum of each ear daily for three
days with the concentrations 10, 25 and 50%. Acetone:olive oil (4 +1)
was used as vehicle. Five days after study initiation, the mice were
injected intravenously into a tail vein with radio-labbeld thymidine and
sacrificied five hours later.
No mortality occured and no signs of local irritation or systemic
toxicity were present. Stimulation indexes were 12.80, 16.10 and 15.74,
all being larger than the cut-off of 3. Consequently, the test substance
is considered to be a skin sensitiser.
No study with the registered substance is available but for a closely
related structure differing by one methyl group at the oxime carbon atom
from the registered substance. The test substance is a C9 aldoxime
whereas the registered substance is a C9 ketoxime. The C9 aldoxime
showed a clear potential for skin sensitisation in an LLNA study and
therefore the registered substance is also labelled as a skin sensitiser
according to this read across. A repetition of the LLNA study appears to
In the study, the test item dissolved in acetone:olive oil (4+1) was
assessed for its possible contact allergenic potential. The study was
performed according to OECD 429 guideline and GLP.
For this purpose a local lymph node assay was performed using test item
concentrations of 10, 25, and 50%.
The animals did not show any clinical signs during the course of the
study and no cases of mortality were observed. A statistically
significant increase in ear thickness was observed in the animals
treated with 10 and 25 % test item concentration (p < 0.001). In this
study Stimulation Indices of 12.80, 16.10 and 15.74 were determined with
the test item at concentrations of 10, 25 and 50 % in acetone:olive oil
(4 +1) respectively. The test item was found to be a skin sensitiser.
Based on the available data, no sub-classification into Cat. 1A or 1B
The available experimental test data are reliable and suitable for
classification purposes under Regulation 1272/2008. The stimulation
indices in the LLNA (OECD 429) exceeded the cut-off value of 3.
No EC3could be established. As a result, the substance is
considered to be classified for skin sensitization (GHS Cat. 1) under
Regulation (EC) No. 1272/2008,as amended for the fourteenth time in
Regulation (EC) No. 2020/217.Based on the available data, no
distinction between category 1A and 1B according to CLP can be made as
the lowest dose tested was at 10 %.
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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