(carboxylatomethyl)dimethyltetradecylammonium

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Testing was conducted between 31 August 2005 and 18 October 2005.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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:

Sponsor's identification: FSM-005W
Description: white solid
Batch number: 2005-01
Date received: 23 August 2005
Storage conditions: room temperature in the dark under nitrogen over silica gel
The integrity of supplied data relating to the identity, purity and stability of the test material is the responsibility of the Sponsor.

Analytical monitoring:

yes

Details on sampling:

Aliquots of the sample solutions were taken from the flasks at various times and the pH of each solution recorded.

Buffers:

pH 4- Monopotassium citrate (0.05 mol dm-3) -Sodium chloride (0.009 mol dm-3)
pH-7 - Disodium hydrogen orthophosphate (anhydrous) (0.03 mol dm-3), Potassium dihydrogen orthophosphate (0.02 mol dm-3), Sodium chloride (0.02 mol dm-3)
pH-9 - Disodium tetraborate (0.01 mol dm-3), Sodium chloride (0.02 mol dm-3)

The buffer solutions were filtered through a 0.2 gm membrane filter to ensure they were sterile before commencement of the test. Also these solutions were subjected to ultrasonication and degassing with nitrogen to minimise dissolved oxygen content.

Details on test conditions:

Preparation of samples
Sample solutions were prepared in stoppered glass flasks at a nominal concentration of 1 g/l in the three buffer solutions.
The solutions were shielded from light whilst maintained at the test temperature.

Duration:

5 d

pH:

4

Temp.:

50 °C

Initial conc. measured:

0.992 g/L

Duration:

5 d

pH:

7

Temp.:

50 °C

Initial conc. measured:

0.883 g/L

Duration:

5 d

pH:

9

Temp.:

50 °C

Initial conc. measured:

0.968 g/L

Number of replicates:

3

Positive controls:

not specified

Negative controls:

not specified

Transformation products:

no

Key result

pH:

4

Temp.:

25 °C

DT50:

> 1 yr

Type:

not specified

Key result

pH:

7

Temp.:

25 °C

DT50:

> 1 yr

Type:

not specified

Key result

pH:

9

Temp.:

25 °C

DT50:

> 1 yr

Type:

not specified

Details on results:

It was noted that the chromatography generated in this test was of poorer quality than would have been desirable, due to the buffer salts present and the general unsuitability of the test material to reverse phase HPLC, (see partition coefficient and adsorption coefficient sections). However, the method was of adequate accuracy to assess any concentration change over the course of the test. Additionally, it was anticipated that the test material would not degrade and as such, the method would not be required to assess significant decreases in concentration or changes in peak profiles.

Validity criteria fulfilled:

yes

Conclusions:

The estimated half-life at 25°C of the test material at pH4, 7, and 9 is >1year.

Executive summary:

The estimated half-life at 25°C of the test material are shown in the following table:

pH	Estimated half life at 25 °C
4	>1 year
7	>1 year
9	>1 year

The detemination was carried out using Method C7 of Commission Directive 92/69/EEC.

Description of key information

The estimated half-life at 25°C of the test material are shown in the following table:

pH	Estimated half life at 25 °C
4	>1 year
7	>1 year
9	>1 year

The detemination was carried out using Method C7 of Commission Directive 92/69/EEC.

Key value for chemical safety assessment

Half-life for hydrolysis:

1 yr

at the temperature of:

25 °C