2-isopropyl-N-hydroxyethyl 1,3-oxazolidine;methyl carbonato-N-ethyl-2-isopropyl-1,3-oxazolidine;reaction mass of: carbonato-bis-N-ethyl-2-isopropyl-1,3-oxazolidine

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 1998-05-20 to 1998-11-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study is regarded as reliable without restrictions because it was conducted in compliance with GLP regulation and guideline.

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)

Version / remarks:

cited as: Directive 92/69/EEC

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 111 (Hydrolysis as a Function of pH)

Deviations:

no

Principles of method if other than guideline:

During the course of method development it was observed that Incozol LV rapidly degraded in water. Two analytical methods were developed, one for the quantification of the test material Incozol LV and the other for quantification of the major degradation product. Three stock solutions of Incozol LV were prepared (nominally 500 mg/L) in double distilled water (acidified, basified and unadjusted). These stock solutions were decanted into colour coded septum sealed vials (100 mL), and placed into a water bath set at 20 °C. Samples were then analysed at appropriate time intervals for both Incozol LV and the major degradation product.

GLP compliance:

yes

Radiolabelling:

no

Analytical monitoring:

yes

Buffers:

- pH: 9.75
- Type and final molarity of buffer: unadjusted double distilled water
- Composition of buffer: unadjusted double distilled water

- pH: acidified, 2.3
- Type and final molarity of buffer: 512.5 mg/L
- Composition of buffer: 1:9; 0.1M HC1:Water

- pH: basified, 12.2
- Type and final molarity of buffer: 488.5 mg/L
- Composition of buffer: 1:9; 0.1M KOH:Water

Duration:

5 d

pH:

2.3

Temp.:

20 °C

Initial conc. measured:

512.5 mg/L

Duration:

5 d

pH:

9.3

Temp.:

20 °C

Initial conc. measured:

521.5 mg/L

Duration:

5 d

pH:

12.2

Temp.:

20 °C

Initial conc. measured:

488.5 mg/L

Number of replicates:

3

Positive controls:

no

Negative controls:

no

Transformation products:

not specified

Key result

pH:

4

Temp.:

20 °C

DT50:

< 1 h

Key result

pH:

7

Temp.:

20 °C

DT50:

< 1 h

Key result

pH:

9

Temp.:

20 °C

DT50:

< 1 h

Details on results:

The behaviour of Incozol LV in water and under both acidic and basic conditions was investigated over 5 days. It was shown that under all conditions tested Incozol LV decomposed rapidly (total decomposition within 1 h). Furthermore, the major decomposition product could be analysed by gas chromatography and was shown to be stable under the conditions tested over a period of five days in a water bath set at 20 °C. The decomposition product could not be identified.

 Stability data in unadjusted water

Sample number	Elapsed time / hours	Analysis batch	Peak area found	Reactant Concentration (g/L)	pH
1	0	NEUT4	71159	0.56	9.75
2	0.25	NEUT4	71309	0.56	9.67
3	0.5	NEUT4	73672	0.58	9.70
4	0.75	NEUT4	74483	0.59	9.70
5	1	NEUT4	71294	0.56	9.26
6	2	NEUT4	71184	0.56	9.92
7	3	NEUT4	67292	0.53	9.48
8	4	NEUT4	72855	0.57	9.80
9	24	NEUT4	63794	0.50	9.51
10	28	NEUT4	66317	0.52	9.84
11	48	NEUT4	63342	0.50	9.82
12	52	NEUT4	70275	0.55	9.96
13	72	NEUT4	73346	0.58	9.80
14	120	NEUT4	76385	0.60	9.88

.

Stability data (acidified)

Sample number	Elapsed time / hours	Analysis batch	Peak area found	Reactant Concentration (g/L)	pH
1	0	AQSTAB1	75329	0.54	2.27
2	1	AQSTAB1	72762	0.52	2.37
3	2	AQSTAB1	71267	0.51	2.34
4	3	AQSTAB1	71719	0.51	2.29
5	4	AQSTAB1	77210	0.55	2.24
6	24	AQSTAB4	37064	0.41	2.36
7	48	AQSTAB4	43526	0.47	2.33
8	72.25	AQSTAB4	65276	0.65	2.32
9	96	AQSTAB4	71105	0.69	2.28
10	120	AQSTAB4	48869	0.52	2.20

 

Stability data (basified)

Sample number	Elapsed time / hours	Analysis batch	Peak area found	Reactant Concentration (g/L)	pH
1	0	AQSTAB1	74155	0.53	12.10
2	1	AQSTAB1	72645	0.52	12.23
3	2	AQSTAB1	68627	0.49	12.27
4	3	AQSTAB1	74497	0.53	12.23
5	4	AQSTAB1	75519	0.54	12.18
6	24	AQSTAB4	47305	0.51	12.15
7	48	AQSTAB4	53043	0.55	12.16
8	72	AQSTAB4	64818	0.65	12.16
9	96	AQSTAB4	63757	0.64	12.09
10	120	AQSTAB4	25436	0.30	12.08

 

Validity criteria fulfilled:

not applicable

Conclusions:

It was shown that under all conditions tested Incozol LV decomposed rapidly (total decomposition within 1 h).

Executive summary:

A study equivalent to Directive 92/69/EEC method C.7 was conducted to determine the behaviour of Incozol LV in water, and under acidic and basic conditions investigated over time. Therefore, three stock solutions of Incozol LV were prepared (nominally 500 mg/L) in double distilled water (acidified, basified and unadjusted). These stock solutions were decanted into colour coded septum sealed vials (100 mL), and placed into a water bath set at 20 °C. Samples were then analysed at appropriate time intervals for both Incozol LV and the major degradation product. It was shown that under all conditions tested Incozol LV decomposed rapidly (total decomposition within 1 h). Furthermore, the major decomposition product could be analysed by gas chromatography and was shown to be stable under the conditions tested over a period of five days in a water bath set at 20 °C.

Description of key information

Incozol LV decomposed rapidly with a total decomposition within 1 h in water, acidic and basic conditions at 20 °C.

Key value for chemical safety assessment

Half-life for hydrolysis:

1 h

at the temperature of:

20 °C

Additional information

A study equivalent to Directive 92/69/EEC method C.7 was conducted to determine the behaviour of Incozol LV in water, and under acidic and basic conditions investigated over time. Therefore, three stock solutions of Incozol LV were prepared (nominally 500 mg/L) in double distilled water (acidified, basified and unadjusted). These stock solutions were decanted into colour coded septum sealed vials (100 mL), and placed into a water bath set at 20 °C. Samples were then analysed at appropriate time intervals for both Incozol LV and the major degradation product. It was shown that under all conditions tested Incozol LV decomposed rapidly (total decomposition within 1 h). Furthermore, the major decomposition product could be analysed by gas chromatography and was shown to be stable under the conditions tested over a period of five days in a water bath set at 20 °C.