1,3-dimethylimidazolidin-2-one

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 January to 21 January 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study carried out in compliance with an internationally recognised guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 111 (Hydrolysis as a Function of pH)

GLP compliance:

yes

Radiolabelling:

no

Analytical monitoring:

yes

Details on sampling:

- Sampling intervals for the parent: Day 0, Day 2, Day 5
- Sampling method: 5µL of test solution taken and injected into a high performance liquid chromatograph
- Sampling methods for the volatile compounds, if any: test solutions kept in 10ml vacuum vials filled to the top and hermetically sealed
- Sampling intervals/times for pH measurements: not relevant, the substance contains no ionisable groups
- Sampling intervals/times for sterility check: day 0 and Day 5
- Sample storage conditions before analysis: not relevant samples analysed immediately

Buffers:

- pH: 4.0; 7.0; 9.0
- Type and final molarity of buffer: pH4 0.2M acetic acid/0.2M sodium acetate; pH7and 9 0.1M potassium dihydrogenphosphate and 0.05M borax;
- Composition of buffer:
pH 4.0 buffer solution: prepared by mixing 255 mL of 0.2M acetic acid and 57 mL of 0.2M sodium acetate in water.
pH 7.0 buffer solution: prepared by mixing 198 mL of 0.1M potassium dihydrogenphosphate in water and 118 mL of 0.05M borax in water.
pH 9.0 buffer solution: prepared by mixing 54 mL of 0.1M potassium dihydrogenphosphate in water and 250 mL of 0.05M borax in water.

Details on test conditions:

TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: 10 ml vacuum vials hermetically closed with rubber stopper and screw cap
- Sterilisation method: autoclave, 120°C, 1hour
- Lighting: not applicable
- Measures taken to avoid photolytic effects: test vessels protected from light by wrapping in aluminium foil
- Measures to exclude oxygen: test solutions deaeration by bubbling nitrogen gas through sterilized 0.2µm membrane filters for 5 minutes
- Details on test procedure for unstable compounds: not applicable
- If no traps were used, is the test system closed/open: closed (hermetically sealed vacuum vials
- Is there any indication of the test material adsorbing to the walls of the test apparatus?: no

TEST MEDIUM
- Volume used: 10ml
- Kind and purity of water: lab reagent grade, sterilised

- Preparation of test solution: One mL of the test substance was measured into a 100 mL volumetric flask and made up to volume with sterile water to prepare the stock test solution. Two mL of the stock test solution was measured into a 200-mL volumetric flask and made up to volume with sterilized/deaerated buffer. The solutions obtained were used as test solutions. Each test solution was pipetted into ten 10 mL vacuum vials, 10 mL per vial , and hermetically closed with a rubber stopper and screw cap.

- Renewal of test solution: not applicable
- Identity and concentration of co-solvent: not applicable

OTHER TEST CONDITIONS
The prepared test solutions were held in a thermostatic water bath set at 50°C for the duration of the test.

Duration:

5 d

pH:

4

Temp.:

50 °C

Initial conc. measured:

105.26 mg/L

Duration:

5 d

pH:

7

Temp.:

50 °C

Initial conc. measured:

105.08 mg/L

Duration:

5 d

pH:

9

Temp.:

50 °C

Initial conc. measured:

104.84 mg/L

Number of replicates:

Two per time point and pH

Positive controls:

no

Negative controls:

no

Preliminary study:

The preliminary study showed that the test substance was stable in water at pH 4, 7 and 9.
The main study was not required.

Transformation products:

no

Details on hydrolysis and appearance of transformation product(s):

No measurable hydrolysis was seen during the study

% Recovery:

100

pH:

4

Temp.:

50 °C

Duration:

5 d

Remarks on result:

hydrolytically stable based on preliminary test

% Recovery:

100

pH:

7

Temp.:

50 °C

Duration:

5 d

Remarks on result:

hydrolytically stable based on preliminary test

% Recovery:

100.3

pH:

9

Temp.:

50 °C

Duration:

5 d

Remarks on result:

hydrolytically stable based on preliminary test

pH:

4

Temp.:

50 °C

Remarks on result:

hydrolytically stable based on preliminary test

Key result

pH:

7

Temp.:

50 °C

Remarks on result:

hydrolytically stable based on preliminary test

pH:

9

Temp.:

50 °C

Remarks on result:

hydrolytically stable based on preliminary test

Other kinetic parameters:

Not applicable no measurable hydrolysis was seen during the study

Details on results:

TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes
- Anomalies or problems encountered (if yes): None

MAJOR TRANSFORMATION PRODUCTS
Not applicable, the substance is stable to hydrolysis

MINOR TRANSFORMATION PRODUCTS
Not applicable, the substance is stable to hydrolysis

INDICATION OF UNSTABLE TRANSFORMATION PRODUCTS:
Not applicable, the substance is stable to hydrolysis

PATHWAYS OF HYDROLYSIS
Not applicable, the substance is stable to hydrolysis

SUPPLEMENTARY EXPERIMENT (if any): RESULTS:
Not applicable, the substance is stable to hydrolysis

Validity criteria fulfilled:

yes

Conclusions:

The substance is stable to hydrolysis at pH 4.0, 7.0 and 9.0

Description of key information

The substance is stable to hydrolysis at pH 4.0, 7.0 and 9.0

Key value for chemical safety assessment

Half-life for hydrolysis:

1 yr

at the temperature of:

25 °C

Additional information

The substance is stable to hydrolysis for 5 days at 50°C in a preliminary hydrolysis test carried out in accordance with OECD test Guideline 111. Further work is not undertaken as it can be concluded from the results of the preliminary test that the substance will have a half-life time of greater than 1 year at 25°C at pH 4, 7 and 9.