Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In a bacterial reverse mutation assay (Salmonella strains TA98, TA100, TA1535, TA1537, TA1538) ethoxypropyl acetate (EPA) tested up to 5000 ug/plate did not produce evidence of mutation with or without exogenous metabolic activation by rat liver S-9. In E. coli WP2 uvr A, the read across substance methoxypropyl acetate did not show any signs of mutagenic activity.

In cultured Chinese hamster ovary (CHO) cells (strain K1-BH4), EPA tested at concentrations up to 2300 ug/ml did not induce statistically significant increases in the incidence of chromosome aberrations either in the absence or presence of exogenous metabolic activation by rat liver S-9.

Propylene glycol methyl ether was not mutagenic under the conditions of this test. This result can be considered representative of the close structural analogue Propylene glycol ethyl ether, which is in turn the rapidly created in vivo metabolite of Propylene glycol ethyl ether acetate, the substance that is the subject of this dossier. On this basis, the study indicates that Propylene glycl ethyl ether acetate (ethoxyypropyl acetate) is not mutagenic. It should be noted that metabolic activation was not used in this study.

In a reliable in vivo mouse micronucleus study using the surrogate substance 1 -methoxypropan-2 -ol, which is a close structural analogue to the key in vivo metabolite of ethoxypropyl acetate (1 -ethoxypropan-2 -ol), no increase in micronucleated polychromatic erythrocytes was seen up to and including doses that caused mortality.

Whilst the dataset is not ideal (some surrogate substance use and one study without metabolic activation) the evidence is sufficiently compelling to conclude that ethoxypropyl acetate does not exhibit any mutagenic potential.


Short description of key information:
Bacterial reverse mutation: negative, with and without metabolic activation
Chromosome abberation/cytogenicity: negative with and without metabolic activation

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Ethoxypropyl acetate does not exhibit any mutagenic potential and therefore does not require classification for this end point.