Registration Dossier
Registration Dossier
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EC number: 642-362-8 | CAS number: 1190630-03-5
Endpoint summary
Administrative data
Description of key information
The key data is from a reliable (Klimisch 2) 26 week oral gavage study using docosan-1-ol in rats. In this study a NOAEL > 1000 mg/kg was reported. A read across from a reliable 13 week dietary study in rats using hexan-1-ol reported a NOAEL of 1127 mg/kg (Scientific Associates Inc., 1966). No adverse effects were noted at any of the dose levels administered during the study.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
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.
Data from a reliable (Klimisch 2) 26 week oral gavage study using docosan-1-ol in rats reported a NOAEL > 1000 mg/kg (Iglesias 2002a). In addition a 26 week oral study in dogs reported a NOAEL >2000 mg/kg [Iglesias, 2002a). Chronic and sub-chronic toxicity studies have shown that long chain alcohols (LCA) are of low toxicity. Furthermore, combined repeated-dose studies with developmental endpoints, as well as reproductive and developmental studies showed no effects at the highest dose tested. Consequently in line with the read-across justification included, Ziegler Bottoms are considered to be of low toxicity with a NOAEL established at 1000mg/kg.
Justification for classification or non-classification
These findings do not warrant the classification of Ziegler Bottoms as repeated dose 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.
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