Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

The bacterial mutagenicity of alcohol polyglycosides (APGs) was examined with hexyl-D-glucoside, branched and linear C9-11-alkyl glycosides and C10-16-alkyl glycosides using several strains of S. typhimurium or E. coli. All tests were conducted according or similar to OECD Guideline 471 in the presence and absence of metabolic activation. The results revealed that APG can be considered as non-mutagenic.

The clastogenic potential of APG in vitro was analysed by a chromosome aberration test according to OECD 473 in Chinese Hamster lung fibroblasts with C10-16-alkyl glycosides. No chromosomal aberrations (ABs) were induced in the presence and absence of metabolic activation and therefore, APG are considered to be non-clastogenic in vitro.

Testing of the mammalian mutagenicity in vitro was done by a Mouse Lymphoma Assay with C8-10-alkyl glycosides and had a clear negative outcome, hence it can be concluded that APG are not mutagenic in mammalian cells.

The clastogenic potential was additionally tested in vivo by a murine micronucleus assay which indicated as well a negative result.

Considering all facts together it can be concluded, that APG have no genotoxic potential, neither in vitro nor in vivo.

 


Short description of key information:
Several studies investigating the genetic toxicity of APGs in-vitro and in-vivo have shown that APGs can be considered as non-genotoxic.

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.