Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In a GLP bacterial reverse mutation assay (Salmonella strains TA98, TA100, TA1535, TA1537, TA1538) ethoxypropanol tested up to 5000 ug/plate did not produce evidence of mutation with or without exogenous metabolic activation by rat liver S-9. In studies using the read across substance methoxypropyl acetate, negative results were obtained using the bacterial strain E Coli WP2 uvr A.

In a guideline and GLP in vitro cytogenetics assay using human lymphocytes, ethoxypropanol tested at concentrations up to 5000 ug/ml did not induce chromosome aberrations with or without exogenous metabolic activation by rat liver S-9.

In a reliable in vitro gene mutation study using mammalian cells (Chinese hamster lung fibroblasts V79) and the test substance methoxypropanol (the methyl analogue of ethoxypropanol), no increase in gene mutations was observed. No metabolic activation was used but the absence of any molecule structures associated with mutagenic properties can be combined with other data to make a reliable prediction for this end point that gentoxicity is not a significant property of this substance.

Detailed justification for using the read across substances methoxypropanol and its acetate ester methoxypropyl acetate can be found in a document attached to chapter 13 of the IUCLID dossier.


Short description of key information:
Bacterial reverse mutation: negative, with and without metabolic activation
Chromosome abberation/cytogenicity: negative with and without metabolic activation
(analogue - methoxypropanol) in vitro gene mutation using mammalian cells: negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The substance has no significant genotoxic properties and therefore classification is not warranted.