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EC number: 941-245-1
CAS number: 1689576-43-9
No data are
available for the reaction product. However, in a direct peptide binding
in vitro assay (DPRA) with
the main component of the reaction mass, i.e.
2-(2-Methylallyl)-cyclododecanon (CAS 62599-49-9), no peptide
reactivity/binding has been observed (BASF 2014; 67V0738/13A420).
Furthermore, no potential for keratinocyte activation has been observed
for this component in an in vitro Keratinocyte activation assay
(LuSens). Due to the complexity of the skin sensitization process, a
combination of several methods addressing key steps of the sensitization
process (protein reactivity (DPRA), activation of keratinocytes (LuSens
or KeratinoSens) and activation of dendritic cells (MUSST or h-CLA T))
are required in a test battery . As an unambiguous result was obtained
after two tests , no further test was performed. In the test battery
evaluation a weight of evidence approach is used. Any two of the three
tests determine the overall results, i.e. any two positive test results
drive the prediction of a sensitizer, while any two negative test
results drive the prediction of a test substance to be a non-sensitizer
(Bauch et al. 2012). Applying the evaluation criteria described for the
test battery, 2-(2-Methylallyl)cyclododecanon-Rein is predicted not to
be a skin sensitizer.
C, Kalle SN, Ramirez-Hernandez T, Eltze T, Fabian E, Teubner W, Mehling
A, van Ravenzwaay B, Landsiedel R. Putting the parts together: Combining
in vitro methods to test for skin sensitizing. Regulatory Toxicology and
Pharmacology 63(3), 489-504, 2012.
No data available for the reaction product.
The present data on dermal sensitization do not fulfill the criteria
laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a
non-classification is warranted.
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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