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EC number: -
CAS number: -
In an LLNA study performed according to OECD
429, three experimental groups of five female CBA/J mice were treated
with test substance 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 vehicle alone (propylene
glycol). 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. The positive control showed appropriate results.
The SI values calculated for the substance
concentrations 5, 10 and 25% were 2.2, 1.7 and 1.8 respectively.
Since there was no indication that the test
substance elicits an SI ≥ 3 when tested up to 25%, FAT 41043/A TE was
considered not to be a skin sensitizer. It was established that the EC3
value (the estimated test substance concentration that will give a SI
=3) (if any) exceeds 25%.
Based on these results, FAT 41043/A TE would
not be regarded as a skin sensitizer. 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 (2007) and the Regulation (EC) No 1272/2008 on classification,
labelling and packaging of substances and mixtures.
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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