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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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