Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

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
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

To cover the endpoint genotoxicity of substance C12-13AE (CAS 66455-14-9), 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 a 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 selected as all study results are negative

Justification for classification or non-classification

Classification criteria according to Regulation (EC) No. 1272/2008 are not fulfilled.