Ethene, homopolymer, oxidized, hydrolyzed, distn. residues, from C16-18 alcs. manuf.

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Ziegler Bottoms are characterized as comprising of two primary constituents; icosan-1-ol and docosan-1-ol. Together these constituents represent a structural class of components (alcohols) that constitute approximately 82% of the composition of Ziegler Bottoms. Study data, where available, for each of these primary constituents has been evaluated and considered together. In a conservative approach the most sensitive study result from across the two constituents has been identified and used to address the endpoint in question. 

In a reliable (Klimisch 1) OECD 406 GLP compliant study the skin sensitising potential of octadecan-1-ol has been assessed. Octadecan-1-ol data in this instance has been used provide read-across data for the sensitisation endpoint of both icosan-1-ol and docosan-1-ol. In this study octadecan-1-ol was reported to not be a skin sensitiser when tested using the Magnusson and Kligman guinea pig maximization procedure. Consequently in line with the read-across justification included, Ziegler Bottoms are considered not to be sensitising.

Migrated from Short description of key information:
The key study for sensitisation was a reliable (Klimisch 1) OECD 406 study with octadecan-1-ol. In this study the test substance was reported to be non-sensitising.

Justification for classification or non-classification

These findings do not warrant the classification of Ziegler Bottoms as a sensitiser under the new Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) and under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.