Registration Dossier

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

3-(3-Hydroxy-propyl)-oxazolidin-2-on is a liquid which is miscible with water. lt has a very low volatility and a log Pow of -1.22.

 

Evidence for systemic availability of 3-(3-Hydroxy-propyl)-oxazolidin-2-on comes from the subacute toxicity study in rats (BASF AG, 2004). In this study with dietary concentrations of 0, 750, 3000, and 12000 mg/kg feed (corresponding to 0 and about 70, 290 and 1160 mg/kg bw/day), clinico-chemical effects (decreased serum urea in males and females; increased red blood cells and hematocrit in females) were observed at 12000 mg/kg feed. These effects are clear indicators of systemic availability of 3-(3-Hydroxypropyl)-oxazolidin-2on. Since these changes were reversible within a 2-week recovery period, excretion of 3-(3-Hydroxy-propyl)-oxazolidin-2-on and its metabolites appears to be rather rapid.

 

Considering the chemical structure of 3-(3-Hydroxy-propyl)-oxazolidin-2-on, metabolism may consist of:

-cleavage of the oxazolidinon ring at the ester moiety;

- oxidation of the 3-hydroxy group to the acid via intermediate formation of an aldehyde;

-conjugation of the 3-hydroxy-group.

 

All potential metabolites of the metabolic pathway described above are more polar and more water soluble than the parent and are expected to be excreted predominantly via the urine.

 

Studies on genotoxicity (Ames-Test, in vitro cytogenetics) were negative, i.e. there is no indication of a reactivity of 3-(3-Hydroxy-propyl)-oxazolidin-2-on or its metabolites under the test conditions.

 

Taking into account the low log Pow as well as the results of the 28-day study in rats and the considerations on metabolism, accumulation of 3-(3-Hydroxy-propyl)-oxazolidin-2-on is considered to be unlikely.