Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:


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.

·         Bauch 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.

Respiratory sensitisation

Endpoint conclusion
Additional information:

No data available for the reaction product.

Justification for classification or non-classification

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.