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EC number: -
CAS number: -
No signs of systemic toxicity were observed
in any of the animals examined. Variations in ear thickness during the
observation period were less than 25% from Day 1 pre-dose values.
Purple/red test substance remnants were present on the dorsal surface of
the ears of all animals at 10 and 25% throughout the observation period,
which prevented scoring for erythema.
Based on the results, the highest test
substance concentration selected for the main study was a 25%
results - main study:
Skin reactions / Irritation (see Table 3)
Purple/red test substance remnants were
present on the dorsal surface of the ears of all animals at 5, 10 and
25% throughout the observation period, which prevented scoring for
Systemic toxicity (Body weights, see Table 3)
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. The body weight loss
noted for several animals across the dose groups was considered not
toxicologically significant since the changes were slight in nature and
no concentration-related incidence was apparent.
Macroscopy of the auricular lymph nodes and
surrounding area (Table 4)
The majority of auricular lymph nodes were
considered normal in size, except for the nodes of one animal at 5% and
three animals at 25%, which appeared larger in size when compared to the
other treated groups. No macroscopic abnormalities of the surrounding
area were noted in any of the animals.
In the main study, 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 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 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
(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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