2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)propane-1,3-diol

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

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)

Qualifier:

according to guideline

Guideline:

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

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: Product no. B4429, Lot no. SLBK5235V
- Expiration date of the lot/batch: 30 April 2018
- Purity test date: na

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

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no

Radiolabelling:

no

Analytical monitoring:

yes

Details on sampling:

- Sampling intervals for the parent/transformation products: 0 and 120h
- Sampling method: -
- Sampling methods for the volatile compounds, if any: not applicable
- Sampling intervals/times for pH measurements: 0 and 120h
- Sampling intervals/times for sterility check: not applicable
- Sample storage conditions before analysis: not applicable (no storage)
- Other observation, if any (e.g.: precipitation, color change etc.): none

Buffers:

- pH: 4, 7, 9
- Type and final molarity of buffer:
- Composition of buffer:
pH 4.0: 76.5 mL 0.1 M sodium acetate and 423.5 mL 0.1 M acetic acid;
pH 7.0: 250 mL 0.1 TRIS buffer and 233 mL 0.1 M hydrochlorid acid diluted to 500 mL with ultra-pure water;
pH 9.0: 53.5 mL 0.2 M sodium hydroxide and 125 mL 0.1 M boric acid and potassium chloride diluted to 500 mL with ultra-pure water)

Details on test conditions:

TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: 20 mL headspace vials
- Sterilisation method: sterile working conditions
- Lighting: no information available
- Measures taken to avoid photolytic effects: no information available
- Measures to exclude oxygen: test tubes were filled up with test solutions
- Details on test procedure for unstable compounds: not applicable
- Details of traps for volatile, if any: not applicable
- If no traps were used, is the test system closed/open: no information available
- Is there any indication of the test material adsorbing to the walls of the test apparatus? none
TEST MEDIUM
- Volume used/treatment: 20 mL
- Kind and purity of water: ultra-pure sterile water
- Preparation of test medium: 250 mg dissolved in each buffer solution to a total volume of 250 mL
- Renewal of test solution: none
- Identity and concentration of co-solvent: not applicable

Duration:

120 h

pH:

4

Temp.:

50 °C

Initial conc. measured:

0.99 µg/L

Duration:

120 h

pH:

7

Temp.:

50 °C

Initial conc. measured:

0.99 µg/L

Duration:

120 h

pH:

9

Temp.:

50 °C

Initial conc. measured:

0.95 µg/L

Number of replicates:

5 per pH

Positive controls:

no

Negative controls:

yes

Preliminary study:

Recovery after 120h at 50°C:
- pH 4: 105%
- pH 7: 95%
- pH 9: 96%
Therefore, it was concluded that the substance is hydrolytically stable and no further experiments were conducted.

Transformation products:

not measured

% Recovery:

100

pH:

4

Temp.:

50 °C

Duration:

120 h

Remarks on result:

hydrolytically stable based on preliminary test

% Recovery:

95

pH:

7

Temp.:

50 °C

Duration:

120 h

Remarks on result:

hydrolytically stable based on preliminary test

% Recovery:

96

pH:

9

Temp.:

50 °C

Duration:

120 h

Remarks on result:

hydrolytically stable based on preliminary test

Key result

Remarks on result:

hydrolytically stable based on preliminary test

Details on results:

TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes
- Anomalies or problems encountered (if yes):

MAJOR TRANSFORMATION PRODUCTS: - not applicable

MINERALISATION (distinguish between dark and irradiated samples): not applicable

INDICATION OF UNSTABLE TRANSFORMATION PRODUCTS: none

VOLATILIZATION (at end of study): none

UNIDENTIFIED RADIOACTIVITY (at end of study): not applicable

PATHWAYS OF HYDROLYSIS: not applicable

The hydrolysis of the substance as a function of pH was determined in a preliminary test according to OECD Test Guideline 111 under GLP conditions.

As no hydrolysis was observed at pH 4, 7 and 9 at 50°C for 120h, it was concluded that the substance is hydrolytically stable and the hydrolysis was not investigated further.

Validity criteria fulfilled:

yes

Executive summary:

The hydrolysis of the substance as a function of pH was determined in a preliminary test according to OECD Test Guideline 111 under GLP conditions.

As no hydrolysis was observed at pH 4, 7 and 9 at 50°C for 120h, it was concluded that the substance is hydrolytically stable and the hydrolysis was not investigated further.

Description of key information

In a preliminary test, the substance was hydrolytically stable.