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EC number: 619-217-2
CAS number: 96487-85-3
An LLNA skin sensitisation study was performed according to
OECD/EC test guidelines and GLP principles. Based on the results of a
pre-screen test, the test concentrations were selected at 5%, 10% and
25% w/w. No irritation was observed in any of the animals.
Scaliness was noted for two animals treated at 5% and all animals
treated at 10% and 25% on Day 6. All auricular lymph nodes of the
animals of the experimental and control groups were considered normal in
size. No macroscopic abnormalities of the surrounding area were noted
for any of the animals. 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. Mean DPM/animal
values for the experimental groups treated with test item concentrations
5, 10 and 25% were 723, 975 and 755 DPM, respectively. The mean
DPM/animal value for the vehicle control group was 661 DPM. The SI
values calculated for the test item concentrations 5, 10 and 25% were
1.1, 1.5 and 1.1, respectively. As the SI appeared not to be ≥ 3
when tested up to 25% w/w, Norethyl was considered not to be a skin
Based on these results, Norethyl would not be regarded as a skin
sensitizer according to the recommendations made in the test guidelines.
The test item 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 (2015) (including all amendments) and the
Regulation (EC) No 1272/2008 on classification, labelling and packaging
of items and mixtures (including all amendments).
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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