Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

Sensitization

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.