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EC number: 485-390-4
CAS number: -
For the registered substance, one reliable
(Klimisch 1) skin sensitisation study (LLNA) was available.
A LLNA/IMDS was carried out in female NMRI
mice after epicutaneous application of a formulation containing 0, 2, 10
or 50% of the registered substance for 3 consecutive days onto both ears
of the animals. This study did neither point to a non-specific
(irritating) nor to a specific immunostimulating (sensitizing) potential
of the substance. This applies to NMRI mice, for weight and cell counts
of the draining lymph nodes as well as ear swelling and ear weight
indices evaluated after application. In summary, no antigen specific
activation of the cells of the immune system via dermal route was
determined after application of up to and including 50% of the
registered substance by the method used. Therefore, the concentration of
50% turned out to be the NOEL for the parameters investigated in this
study with respect to skin sensitization (Bayer, 2006).
These results are supported by a repeated
human insult patch test, which was completed by 110 participants. In
this study the registered substance did not indicate a clinically
significant potential for allergic contact sensitization (see IUCLID
section 7.10.4). (CPT, 2007)
Based on the results of the skin
sensitization studies, the test item is not subjected to classification
according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (GHS,CLP).
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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