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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 500-201-8 | CAS number: 68213-23-0 1 - 2.5 moles ethoxylated
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
To cover the endpoint genotoxicity of substance C12-18AE (CAS 68213-23-0), studies from similar substances were taken for read-across. Read-across is justified because the length of the alkyl chain and the grade of ethoxylation does not exert any meaningful influence on genotoxicity. Moreover, the structure of alcohol ethoxylates (AE) is not of concern for potential genotoxicity and in all available in-vitro and in-vivo genotoxicity assays, there was no indication of genetic toxicity of broad range of structurally different AE (HERA, 2009).
Studies which were undertaken in vitro using a number of test systems have resulted in negative findings.
The results of several tests with AE using several strains of S. typhimurium or E. coli, were all negative. Testing with mammalian cell lines for a chromosomal aberration assay with AE C16-18 gave a negative result as did the mouse lymphoma assay with
AE C16-18 and AE C6-10.
The result of in-vivo testing in murine micronucleus assay and a chromosal aberration test with AE C6-10 were as well negative.
Based on the outcome of these tests, AE can be considered as non-genotoxic.
Justification for selection of genetic toxicity endpoint
No study chosen due to woe approach.
Short description of key information:
Ames (OECD 471): not mutagenic in bacteria
Chromosomal Aberration (OECD 473, OECD 474, OECD 475): not clastogenic in mammalian cells
HPRT (OECD 476): not mutagenic in mammalian cells
UDS (OECD 482): not mutagenic in mammalian hepatocytes
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Classification criteria according to 67/548/EEC and
(EC)1272/2008 are not fulfilled.
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.
