Fatty acids, vegetable-oil, esters with sterols, mixed with vegetable-oil glycerides

Water solubility

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

other: SOP 061.00 Issue 7, Determination of Water Solubility Turbidimetric Method

GLP compliance:

not specified

Other quality assurance:

other: GMP compliance

Type of method:

other: turbidity method

Specific details on test material used for the study:

Batch number: XP3647
CAS: 68990-51-2
UVCB
White to very light yellow soft waxy solid

Key result

Water solubility:

0.2 mg/L

Conc. based on:

not specified

Loading of aqueous phase:

10 g/L

Incubation duration:

1 h

Temp.:

21 °C

pH:

6.2

Remarks on result:

other: incubation time not specified

Details on results:

The water solubility was determined to be 0.2 mg/L at 21°C +/- 1°C

Conclusions:

The water solubility was determined to be 0.2 mg/L at 21°C +/- 1°C

Executive summary:

The water solubility was determined using turbidity method. The water solubility was determined to be 0.2 mg/L at 21°C +/- 1°C

Reference 2

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

other: Procedure based on Intertek Pharmaceutical Services Manchester SOP 55.03 Issue 9 and SOP 55.05 Issue 6

Principles of method if other than guideline:

Procedure based on Intertek Pharmaceutical Services Manchester SOP 55.03 Issue 9 (Surface Tension: preparation and Measurement of test Substance using the Krüss K12 Processor Tensiometer) and SOP 55.05 Issue 6 (Basic Operation of the Krüss K12 Tensiometer using Krüss Lab-Desk 2.0 Software). The sample analysis was conducted at 90% concentration according to SOP 55.03 Issue 9 section 6.33 (test substance with solubility< 1g/L)

GLP compliance:

not specified

Type of method:

other: Turbemetric method

Specific details on test material used for the study:

Batch number: XP3647
CAS: 68990-51-2
UVCB
White to very light yellow soft waxy solid

Key result

Water solubility:

>= 8.9 mg/L

Conc. based on:

not specified

Loading of aqueous phase:

1.3 g/L

Incubation duration:

1 d

Temp.:

25 °C

pH:

ca. 7

Remarks on result:

other: No pH assessment of the test solutions was performed

Conclusions:

Water solubility < 8.9 mg/L was reported.

Executive summary:

A mean total solubility value, calculated by addition of the water solubility values for three components determined form the surface tension analysis has been reported. This was based on a loading of 1.3g/L with an incubation period of approximately 1 day at a temperature of 25°C +/- 0.5°C. No pH assessment of the test solutions was performed.

Water solubility < 8.9 mg/L was reported.

Reference 3

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

2018

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

unsuitable test system

Remarks:

please refer to summary section

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

GLP compliance:

not specified

Type of method:

flask method

Specific details on test material used for the study:

Batch number: XP3647
CAS: 68990-51-2
UVCB
White to very light yellow soft waxy solid

Conclusions:

In summary the shake flask study applied for the test item found to be technically not feasible as it provided specific solubility results significantly in excess of the value expected from structural assessment and knowledge of the components. A further assessment of water solubility based on observations from the surface tension testing of the test item and derailed in report reference 1340388 Water solubility assessment from surface tension testing has been prepared to provide additional information. In addition determination of water solubility by turbidity was performed as a non-specific analysis to confirm the expected behavior of the test item in water using a complementary technique and detailed in report reference 1340388 Determination of the water solubility using Turbidity method

Executive summary:

In summary the shake flask study applied for the test item found to be technically not feasible as it provided specific solubility results significantly in excess of the value expected from structural assessment and knowledge of the components. A further assessment of water solubility based on observations from the surface tension testing of the test item and derailed in report reference 1340388 Water solubility assessment from surface tension testing has been prepared to provide additional information. In addition determination of water solubility by turbidity was performed as a non-specific analysis to confirm the expected behavior of the test item in water using a complementary technique and detailed in report reference 1340388 Determination of the water solubility using Turbidity method

Description of key information

The water solubility was determined using turbidity method. The water solubility was determined to be 0.2 mg/L at 21°C ±1°C

Key value for chemical safety assessment

Water solubility:

0.2 mg/L

at the temperature of:

21 °C