Reaction products of behenic acid, Eicosadioic acid and Polyglyceryl-10

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 - 28. 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: 6-5-A
- Expiration date of the lot/batch: 09. May 2019
- Productiondate: 09.May 2016

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

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none

Key result

Water solubility:

16.11 mg/L

Conc. based on:

test mat. (dissolved fraction)

Loading of aqueous phase:

101 mg/L

Incubation duration:

3 d

Temp.:

20 °C

pH:

7.3

Key result

Water solubility:

50.58 mg/L

Conc. based on:

test mat. (dissolved fraction)

Loading of aqueous phase:

301 mg/L

Incubation duration:

3 d

Temp.:

20 °C

pH:

7.42

Key result

Water solubility:

83.67 mg/L

Conc. based on:

test mat. (dissolved fraction)

Loading of aqueous phase:

506 mg/L

Incubation duration:

3 d

Temp.:

20 °C

pH:

> 6 - < 7

Key result

Water solubility:

99.06 mg/L

Conc. based on:

test mat. (dissolved fraction)

Loading of aqueous phase:

600 mg/L

Incubation duration:

3 d

Temp.:

20 °C

pH:

7.35

Key result

Water solubility:

132.94 mg/L

Conc. based on:

test mat. (dissolved fraction)

Loading of aqueous phase:

804 mg/L

Incubation duration:

3 d

Temp.:

20 °C

pH:

7.32

Key result

Water solubility:

169.24 mg/L

Conc. based on:

test mat. (dissolved fraction)

Loading of aqueous phase:

1 000 mg/L

Incubation duration:

3 d

Temp.:

20 °C

pH:

7.34

Conclusions:

The solubility in water of Nomcort HK-P is dependent on the nominal concentration.
In the range of 101 - 1000 mg/L nominal concentration, 16.1 - 169.2 mg/L of Nomcort HK-P were soluble.
Therefore 16.5 % of Nomcort HK-P are water soluble.

Executive summary:

The solubility of the test item Nomcort HK-P in water was determined 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 and 0.2 μm, PTFE). Undissolved particles were observed in both flasks. Dependency

of solubility on amount of the test item (nominal load) was perceived. According

to the guideline, the flask method was used for the determination of the solubility of the

test item in water.

In the main test, six different loading rates of the test item were chosen to study the effect

of the loading rate on the measured water solubility: 101, 301, 506, 600, 804 and

1000 mg/L (nominal). Three flasks 1A - C with the same loading rate (500 mg/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 sampling 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 ± 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. Because of a difference

of less than 15 % in the concentrations on days 2 and 3 and no upward tendency,

the test was finished on day 3.

No Tyndall effect (i.e. a laser beam was not scattered when transmitted through the liquid)

could be observed indicating that no colloidal dispersed particles are present.

Linear dependency of solubility on amount of the test item (nominal load) was perceived in

the main test, too.

Description of key information

OECD Guideline study available,

additionally, Date from previous Notification is available, however, no information on method or details are given.

Key value for chemical safety assessment

Water solubility:

160 mg/L

at the temperature of:

20 °C

Additional information

Nomcort HK-P is an UVCB substance and only a fraction of 16 % is soluble in water.

The determination was performed in the nominal concentration range of 100 - 1000 mg/L. As key value, the concentration of water soluble fraction at nominal 1000 mg/L is given.