Registration Dossier
Registration Dossier
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EC number: 939-562-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
A subacute 28d oral gavage study was conducted to assess the repeat dose toxicity of alcohols, C18-22, distillation residues (CAS No. 1160164-88-4). The test item was dosed to rats up to 1000 mg/kg with no obvious evidence of toxicity. Consequently a dose of 1000 mg/kg/day was considered to be a No-Observed-Effect-Level (NOEL) in this study.
This result is used in a read-across approach in the REACH registration of Alcohols, C12-18, distn. residues.
Key value for chemical safety assessment
Additional information
The repeat dose oral toxicity of alcohols, C18-22, distillation residues (CAS No. 1160164-88-4) was assessed in a 28d subacute study in Han Wistar rats.The study was designed to be compliant with OECD (Guideline No. 407), Directive 96/54/E.C.B.7 and EPA OPPTS guideline 870.3050. In addition this study was conducted in accordance with the OECD Principles of Good Laboratory Practice.The test item was dosed once daily at 0, 100, 300 and 1000mg/kg to group of 5 rats/sex/dose level.
Animals were monitored regularly for viability and for signs of ill health or reaction to the treatment. The following activities were measured and recorded at pre-determined intervals from pretrial until the completion of the study: body weights, food consumption, observations (clinical, detailed functional, standardised arena and cage), functional tests, ophthalmic examinations, haematology, coagulation, clinical chemistry, urinanalysis, gross necropsy, organ weights and histopathology.
There were no treatment-related clinical signs throughout the course of this study. No treatment-related effects were observed during the detailed functional observation investigations. Body weights and food consumption were unaffected by treatment. There were no treatment-related haematology, coagulation or clinical chemistry changes. There were no treatment-related ocular findings and there were no necropsy or histology findings attributed to treatment.
In conclusion, repeat oral administration of alcohols, C18 -22, distillation residues to Han Wistar rats for 28 days at dose levels up to 1000 mg/kg/day was considered to be well tolerated with no obvious evidence of toxicity being noted. Therefore, the dose of 1000 mg/kg /day was considered to be a No-Observed-Effect-Level (NOEL) in this study.
Justification for classification or non-classification
These findings do not warrant the classification of alcohols, C18-22, distillation residues as a repeat dose toxicant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
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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