2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-09-18, 1989-10-20

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: EEC directive 84/449 C10

Deviations:

yes

Remarks:

The test was performed at pH 4 and pH 7 only. The substance solubility at pH 9 is too low.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 111 (Hydrolysis as a Function of pH)

Deviations:

yes

Remarks:

The test was performed onlyat pH 4 and pH 7. At pH 9 the substance solubility is is too low.

GLP compliance:

no

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):


OTHER PROPERTIES (if relevant for this endpoint)
- Solubility in buffer solution at pH 7 : 0.00075 g/L
- Solubility in buffer solution at pH 9 : 0.00003 g/L

The solutions of the test substance are very sensitive to light. Therefore, the solutions were prepared and handled under red light and stored in the darkness

Radiolabelling:

no

Analytical monitoring:

yes

Details on sampling:

- Sampling intervals for the parent/transformation products: At the end of the test
- Sampling method: 2 mL aliquote of the test solution
- Sample storage conditions before analysis: In the dark

Buffers:

- pH: 4
- Type and final molarity of buffer: Standard acetate buffer
- Composition of buffer: (0.1 mole/L acetic acid + 0.1 mole/L sodium acetate ) + 15 mL acetic acid per liter
- pH: 7
- Type and final molarity of buffer: Phosphate buffer
- Composition of buffer: (0.041 mole di-sodium-hydrogenphosphate + 0.028 mole potassium-dihydrogenphosphate) per liter
- pH: 9
- Composition of buffer: (0.043 mole di-sodium-tetraborate + 0.017 mole potassium-dihydrogenphosphate) per liter

Details on test conditions:

TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: Sterlie 100.0 mL amber volumetric flask
- Sterilisation method: Filtration (0.22 µm)
- Measures taken to avoid photolytic effects: Solutions were prepared and handled under red light and stored in the darkness
- Measures to exclude oxygen: By bubbling argon for 5 minutes
- Is there any indication of the test material adsorbing to the walls of the test apparatus? No

Number of replicates:

2

Positive controls:

no

Negative controls:

no

Preliminary study:

The substance was found to be hydrolytically stable in the preliminary tests. See tables below.

Transformation products:

no

% Recovery:

98.6

pH:

4

Temp.:

50 °C

Duration:

5 d

% Recovery:

93.8

pH:

7

Temp.:

50 °C

Duration:

5 d

Remarks on result:

hydrolytically stable based on preliminary test

Table 1. Preliminary test after 2.4 hours at 50 °C.

	pH 4		pH 7
run	1st	2nd	1st	2nd
initial conc. Co in g/L	0.00031	0.00031	0.00031	0.00031
final conc. Ct in g/L	0.00031	0.00031	0.00030	0.00030
100x(Co-Ct)/Co in %	-0.1	-0.5	1.9	0.9
mean value (%)	-0.3		1.4

Negative values of (Co - Ct)/Co are found for several determinations that means that the concentration of the test substance measured at time = t is greater than the concentation at test start: the difference corresponds to the error (precision) of the analysis method.

Table 2. Preliminary test after 5 days at 50 °C.

	pH 4		pH 7
run	1st	2nd	1st	2nd
initial conc. Co in g/L	0.00030	0.00030	0.00030	0.00030
final conc. Ct in g/L	0.00031	0.00030	0.00029	0.00029
100x(Co-Ct)/Co in %	0.5	2.3	7.0	5.5
mean value (%)	1.4		6.2

Validity criteria fulfilled:

yes

Conclusions:

The test substance is stable at pH 4 and 7 (less than 10 % decomposition after 5 days).

Executive summary:

In this guideline (equivalent to OECD 111) study, the test material (EC 404-363-3) was determined to be hydrolytically stable at pH 4 and pH 7

Description of key information

 Study conducted to recognised testing guideline.

Additional information

A study on hydrolysis as a fuction of pH was conducted according to EEC directive 84/449 C.10 (CIBA-GEIGY Ltd. 1989). The test substance is stable at pH 4 and pH 7 (less than 10 % decomposition after 5 days at 50 °C) . However, the hydrolysis test could not be performed at pH 9 because the solubility of the test substance in the buffer solution at pH 9 is too low.

In contact with water the substance will hydrolyse slowly.