Esterification products of glycerol with docosanoic acid, icosanedioic acid and 16-methylheptadecanoic acid

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14. Oct. 2016 - 27.Feb. 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 5-10-A
- Expiration date of the lot/batch: 19. Oct. 2018
- Purity test date: 19. Oct. 2016

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stored in tightly closed vessel at room temperature under dry conditions in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: n/a
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: none expected

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none

Key result

Water solubility:

< 1.74 mg/L

Conc. based on:

test mat.

Loading of aqueous phase:

100 g/L

Incubation duration:

ca. 7 d

Temp.:

20 °C

pH:

>= 6.26 - <= 6.52

Conclusions:

The solubility of the test item Nomcort SG was stated as < 1.74 mg/l at 20.0 +- 0.5 °C.
0.0017 % of the test item was dissolved in water relating to the hihgest nominal concentration of the test item 100 g/L.

Executive summary:

The solubility of the test item Nomvort SG in water was detemined by measurement of DOC concentration in the filtrated test solutions using TOC analyser.

In the pre-test, flasks with nominal concentrations 10 mg/L and 1000 mg/L were shaken at room temperature for three days and measured for DOC after membrane filtration (0.45 µm, PTFE). Undissolved particles were observed in both flasks. The concentration of DOC la below the LOQ of TC (< 1.10 mg/L) in both flasks. According to the guideline, the flask slow-stirring method was used for the determination of the solubility of the test item in water.

In the main test, six different loadting rates of the test item were chosen to study the effect of the loading rate on the measureed water solubility: 10, 30, 50, 60, 80 and 100 g/L (nominal). Three flasks 1A-C with the same lading rate (50 g/L) were used during equilibration. Seven vessels (flasks blank, 1C (for the sampling point 72 h) and 2 - 6) were set onto the shaking apparatus immediately. After 24 +- 2 hours, flask 1B (for the samplign point 48 h) and after 48 +- 2 hours, flask 1A (for the sampling point 24 h) were set on the shaker and all flasks were shaken for further 24 ü- 2 hours at room temperature (20.0 +- 0.5 °C). Then, flasks 1A - 1C were taken from the shaker, samples were taken, membrane filtered and analysed for DOC via TOC analyser. As the measured value from the flask 1C lay above the LOQ of TOC (< 1.35 mg/L) only, the test was prolonged and the flasks 1A-C were measured on days 5 -7. The measured values lay below the LOQ of TOC (< 1.35 mg/L, corresponding to < 1.74 mg/L test item concentration). Therefore, the test was aborted and the flasks 2 -6 were sampled in the same way.

No Tyndall effect (i.e. a laser beam was not scattered when transmitted throuhg the liquid) could be observed indicating that no colloidal dispersed particles are present. As the solubility of such mixtures as the test item showed usually a dependency on nominal load, the dissolved part relating to the nominal concentrations was calculated.

Description of key information

OECD Guideline study, shake flask method

Key value for chemical safety assessment

Water solubility:

1.74 mg/L

at the temperature of:

20 °C

Additional information

value representing LoQ of method.