2-(2-(dimethylamino)ethoxy)-N-(2-(2-(dimethylamino)ethoxy)ethyl)-N-methylethanamine

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12-12-2014 to 09-05-2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 111 (Hydrolysis as a Function of pH)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: PFW-120356
- Expiration date of the lot/batch: not supplied


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark

Radiolabelling:

no

Analytical monitoring:

yes

Details on sampling:

- Sampling intervals for the parent/transformation products: 0h, 24h, 120h, 144h
- Sampling intervals/times for pH measurements: 0h, 24h, 120h, 144h

Buffers:

Buffer solution (pH 4):
- Citric acid 0.06 mol/dm³
- Sodium chloride 0.04 mol/dm³
- Sodium hydroxide 0.07 mol/dm³

Buffer solution (pH 7):
- Disodium hydrogen orthophosphate (anhydrous) 0.03 mol/dm³
- Potassium dihydrogen orthophosphate 0.02 mol/dm³
- Sodium chloride 0.02 mol/dm³

Buffer solution (pH 9):
- Disodium tetraborate 0.01 mol/dm³
- Sodium chloride 0.02 mol/dm³

Details on test conditions:

TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: stoppered glass flasks
- Sterilisation method: no data
- Lighting: the solutions were shielded from light while maintained at the test temperature
- Measures taken to avoid photolytic effects: vessels placed in the dark
- Measures to exclude oxygen: the solutions were subjected to ultrasonication and degassing with nitrogen to minimize dissolved oxygen content
- Details on test procedure for unstable compounds: no data
- Details of traps for volatile, if any : not applicable
- If no traps were used, is the test system closed/open : stoppered flasks
- Is there any indication of the test material adsorbing to the walls of the test apparatus? no data

TEST MEDIUM
- Volume used/treatment : no data
- Kind and purity of water: no data
- Preparation of test medium: no data
- Renewal of test solution: not applicable
- Identity and concentration of co-solvent: not applicable

OTHER TEST CONDITIONS
- Adjustment of pH: no data
- Dissolved oxygen: no data

Duration:

144 h

pH:

4

Temp.:

50 °C

Initial conc. measured:

1.84 - 1.87 g/L

Remarks:

final conc. 1.82 and 1.91 g/L

Duration:

144 h

pH:

7

Temp.:

50 °C

Initial conc. measured:

1.79 - 1.88 g/L

Remarks:

final conc. 1.48 and 0.947 g/L

Duration:

144 h

pH:

9

Temp.:

50 °C

Initial conc. measured:

1.91 - 1.94 g/L

Remarks:

final conc. 1.37 and 1.75 g/L

Number of replicates:

Duplicate aliquots (A and B) of each sample solution

Positive controls:

no

Negative controls:

no

Statistical methods:

no data

Preliminary study:

For the preliminary study, sample solutions at pH 4, 7 and 9 were maintained at 50.0 +/- 0.5°C for a period of 144 hours.
Results from the preliminary tier 1 test showed it was not necessary to undertake further testing at pH 4, pH 7 and pH 9.

Transformation products:

no

% Recovery:

98 - 103

pH:

4

Temp.:

50 °C

Duration:

144 h

Remarks on result:

hydrolytically stable based on preliminary test

% Recovery:

51.6 - 80.6

pH:

7

Temp.:

50 °C

Duration:

144 h

Remarks on result:

other: The 51.6% recovery was considered to be an outlier since it was out-of-agreement with the other time point samples. Therefore the replicate was not used in any subsequent calculations

% Recovery:

71.1 - 90.8

pH:

9

Temp.:

50 °C

Duration:

144 h

Remarks on result:

other: The 71.1% recovery was considered to be an outlier since it was out-of-agreement with the other time point samples. Therefore, the replicate was not used in any subsequent calculations.

pH:

4

Temp.:

25 °C

DT50:

> 1 yr

Key result

pH:

7

Temp.:

25 °C

DT50:

> 1 yr

pH:

9

Temp.:

25 °C

DT50:

> 1 yr

Validity criteria fulfilled:

yes

Conclusions:

The test substance was found to be hydrolytically stable at pH 4, pH 7 and pH 9 with an estimated half-life time greater than 1 year at 25°C, therefore no further testing was performed. The results of the test can be considered reliable without restriction.

Description of key information

Based on a study carried out according to the OECD guideline 111, the substance was found to be hydrolytically stable at pH 4, pH 7 and pH 9 with an estimated half-life time greater than 1 year at 25°C.