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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Carcinogenicity

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Administrative data

Description of key information

Waiver. Study scientifically unjustified

Key value for chemical safety assessment

Justification for classification or non-classification

Based on the weight of evidence, thedata is waived as testing is not a scientifically necessary option for this endpoint.

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 accordance with Column 2 of REACH Annex X, the carcinogenicity study (required in Section 8.9.1) does not need to be conducted since both supporting substances (docoan-1-ol and icosan-1-ol) are not classified as mutagen Category 3, and there is no evidence from repeated dose toxicity studies that these substances in this category have any potential to cause hyperplasia or pre-neoplastic lesions.