Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 310-080-1 | CAS number: 102242-49-9 The complex residue resulting from the vacuum distillation of C6-24 fatty alcohols which is derived from hydrogenation of C6-24 fatty acids methyl esters. It consists predominantly of satd. fatty alcohols having carbon numbers greater than C18, dimerization products, and long chain esters having carbon numbers greater than C32 and boils at > 250°C (482°F) at 10 torr.
Endpoint summary
Administrative data
Description of key information
For a close homologue of the registered substance, one relevant (and reliable) subchronic study (90 day, rat, oral ) is available. The oral NOAEL of 250 mg/kg bw is the result of a read-across approach to the registered substance.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
The subchronic toxicity of a close homologue of the registered substance was investigated in a 90-day study similar to OECD test guideline 408. While the registered substance mainly consists of saturated components, the tested substance has a significant proportion of the corresponding unsaturated fatty alcohols. As a general rule the reactivity (and hence toxicity) is increased while the degree of saturation decreases in a molecule. Therefore, the test substance can conservatively be assumed to represent a worst case with regard to reactivity and thus to be of higher toxicity as the registered substance.
The test substance dose of 250 mg/kg bodyweight was applied orally by gavage using CMC as vehicle five times per week to Wistar rats of both sexes.
No treatment-related adverse systemic effects were observed with any parameter investigated
(clinical signs and mortality, body weight gain, haematology, biochemistry, urinanalysis and (histo-)pathology) . Therefore, the NOAEL of the test substance, and consequently the registered substance, was determined to be 250 mg/kg bodyweight/day.Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
