Registration Dossier
Registration Dossier
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EC number: 642-362-8 | CAS number: 1190630-03-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
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.
The conclusion that the members of the aliphatic alcohol category (C6 to C22) are not expected to impair fertility is based on a weight of evidence approach using data from reproductive screening studies [C12 (dodecanol), C18 (octadecanol)],a fertilitystudy [C22 (docosanol)], together with a lack of effect on the reproductive organs in repeat dose studies over the range of linear and essentially linear alcohols. In addition there have been no other treatment related effects reported in any of the other studies both using icosan-1-ol and other alcohols from the category. Based on this it is concluded that both icosan-1-ol and docosan-1-ol are not expected to impair fertility.
On the basis of this reproductive toxicity information included as part of this submission and in line with the read-across justification it is concluded that Ziegler Bottoms are not likely to impair fertility.
Short description of key information:
A reliable one-generation reproduction study using docosan-1-ol in rats reported a NOAEL of 1000 mg/kg.
A read across feeding study reported a lack of effects on the reproductive organs of rats receiving hexan-1-ol (Scientific Associates Inc., 1966). No adverse effects were noted at any of the dose levels administered during the study.
Effects on developmental toxicity
Description of key information
A reliable developmental toxicity study using docosan-1-ol in rabbits reported a NOAEL for developmental and maternal effects of > 2000 mg/kg.
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.
Based on the weight of evidence from other alcohols across the category it is concluded that icosan-1-ol and docosan-1-ol are unlikely to be a developmental toxicant in the absence of maternal toxicity. Consequently on the basis of this information Ziegler Bottoms are also unlikely to be developmental toxicant in the absence of maternal toxicity.
Justification for classification or non-classification
These findings do not warrant the classification of Ziegler Bottoms as reproductive/developmental toxicant 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.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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