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Additional information

In vitro

An Ames test performed according to OECD guideline 471 and under GLP is available for assessment (LPT, 1998). The substance was examined inSalmonella typhimuriumstrains TA 98, TA 100, TA 102, TA 1535 and TA 1537, in two independent experiments. Ten concentrations were examined in the preliminary test using strain TA 100 ranging from 0.00316 to 100 µl/plate. The test substance was dissolved in aqua ad iniectabilia. Only slight cytotoxicity was observed at the highest tested concentrations of 31.6 and 100 µI/plate. Hence, 100 µl/plate was chosen as top concentration for the main study. The first main test was carried out as plate incorporation test and the second main test as preincubation test. Five concentrations ranging from 1.0 to 100 µl per plate (123 to 12300 µg/plate) were employed for the 1st independent experiment (plate incorporation test) and for the 2nd independent experiment (preincubation test) with and without metabolic activation (Aroclor 1254-induced rat liver).

In the experiments without and with metabolic activation slight cytotoxic effects were noted at 31.6 and 100 µl/plate at all strains. No mutagenic effect was observed up to the cytotoxic concentration of 100 µl/plate (12300 µg/plate) in any of the 5 tester strains in the two independent experiments with and without metabolic activation.

The substance 3-(3-Hydroxypropyl)-oxazolidin-2-on was assessed for its potential to induce structural chromosomal aberrations (clastogenic activity) and/or changes in the number of chromosomes (aneugenic activity) in V79 cells in vitro both in the presence and in the absence of a metabolising system in a GLP study according to OECD guideline 473 (BASF AG, 2004).

According to an initial range-finding cytotoxicity test for the determination of the experimental doses, the test substance did not exhibit any pronounced toxicity up to the highest recommended concentration, i.e. 10 mM (1500 µg/mI). Thus, the following doses were evaluated:

- 1st experiment:

4-hour exposure, 18-hour sampling time, without S-9 mix: 0; 375; 750; 1500 µg/mI;

4-hour exposure, 18-hour sampling time, with S-9 mix: 0; 375; 750; 1500 µg/mI.

- 2nd experiment:

18-hour exposure, 18-hour sampling time, without S-9 mix: 0; 375; 750; 1500 µg/ml;

18-hour exposure, 28-hour sampling time, without S-9 mix: 0; 1500 µg/ml;

4-hour exposure, 28-hour sampling time, with S-9 mix: 0; 375; 750; 1500 µg/mI.

About 2-3 hours prior to harvesting the cells, Colcemid was added to arrest cells at a metaphase-like stage of mitosis (c-metaphases). The substance did not cause any relevant increase in the number of structurally aberrant metaphases incl. and excl. gaps at both sampling times either without S-9 mix or after adding a metabolising system in two experiments performed independently of each other. No increase in the frequency of cells containing numerical aberrations was demonstrated either. Thus, under the experimental conditions of this assay, the substance wasconsidered not to be either a clastogenic or an aneugenic agent under in vitro conditions in V79 cells.

Short description of key information:
In vitro:
gene mutations in bacteria: negative (OECD guideline 471, LPT 1998)
chromosomal aberrations in mammalian cells: negative (OECD guideline 473, BASF AG, 2004))

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the results of the available studies, the substance does not need to be classified according to Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.