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EC number: 946-101-1
CAS number: -
Based on the EC3 value identified in the LLNA,
the test substance is considered to be a moderate skin sensitiser.
A study was conducted to determine the skin
sensitisation potential of the test substance according to OECD
Guideline 429, EU Method B42 and US EPA OPPTS 870.2600 (LLNA), in
compliance with GLP. The 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 substances concentrations of 5, 10 or 25% 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 v/v)). A positive control group
(alpha-hexylcinnamaldehyde) was also included in the experiment. 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.
Mortality/viability, body weights, clinical signs, and irritation (and
other local effects) were recorded as well. No erythema was observed in
any of the animals, scaliness was noted for all animals treated at 25%
and some animals treated at 10% between Days 4 and 6. The majority of
auricular lymph nodes were considered normal in size, except for one
node in one animal treated at 25%, which was considered enlarged. 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 substance concentrations 5, 10 and 25% were 644, 1406 and 2811
DPM, respectively. The mean DPM/animal value for the vehicle control
group was 460 DPM. The SI values calculated for the test substance
concentrations 5, 10 and 25% were 1.4, 3.1 and 6.1, respectively. These
results indicate that the test substance could elicit a SI ≥ 3. The data
showed a dose-response and an EC3 value (the estimated test substance
concentration that will give a SI =3) of 9.7% was calculated. 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. Under the study conditions and based on the EC3 value,
the test substance was considered to be a moderate skin sensitizer (van
on the results of a local lymph node assay, the substance is considered
to be moderately sensitizing, with a classification of Skin Sens. 1B -
H317: May cause an allergic skin reaction according to the CLP
(Regulation 1272/2008/EC) criteria.
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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