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Solubility in organic solvents / fat solubility

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Reference
Endpoint:
solubility in organic solvents / fat solubility
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:
other: Council Regulations EC No 440/2008, Guideline Part A
Version / remarks:
Methods for the Determination of the physical-chemical properties, A.6, “Water solubility”
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: OECD guideline for testing of chemicals No: 105
Deviations:
no
Principles of method if other than guideline:
The 1-octanol solubility of the test item Bayscript Gelbkomponente is determined according OECD Guideline 105 and EC Guideline A.6. The flask method was chosen for the determination of the 1-octanol solubility.
For the main test, a concentration of about 0.4 g/l of the test item for saturation is dissolved in 1-octanol. The vessels are stoppered and stirred on a magnetic stirrer for 24 h, 48 h and 72 h at 30 °C in a thermostated water bath. Following this procedure, the temperature is reduced to 20 °C and is kept in the thermostated water bath for another 24 h. After phase separation by filtration with a disposable syringe filter and/or centrifugation, respectively, the concentration of the test item in the solutions is determined.
GLP compliance:
yes
Specific details on test material used for the study:
Sample number: 2835
Date of receipt: 2016-06-20
Expiry date: 2018-06-17
Medium:
n-octanol
Solubility:
0.022 g/L
Temp.:
20 °C
Test substance stable:
yes
Details on results:
Remark: Increasing 1-octanol solubilities of the test item Bayscript Gelbkomponente between 0.0114 g/l (24hours, Flask 3) and 0.0252 g/l (72 hours, Flask 1) were observed. Therefore the mean value was calculated with the concentrations of Flask 1 and Flask 2.
Test at 20 °C  Flask 1  Flask 2  Flask 3  Mean value of Flask 1 and Flask 2
 1 -Octanol solubility of Bayscript Gelbkomponente  0.0252 g/l  0.0194 g/l  0.0114 g/l  0.022 g/l

Result of the preliminary test: 0.0599 g/l.

Conclusions:
The 1-octanol solubility of the test item Bayscript Gelbkomponente in 1-octanol determined by HPLC at 20 °C was 0.022 g/l.
Executive summary:

The 1-octanol solubility of the test item Bayscript Gelbkomponente in 1-octanol determined by HPLC at 20 °C was:

 Test at 20 °C  Flask 1  Flask 2  Flask 3  Mean value of Flask 1 and Flask 2
 1 -Octanol solubility of Bayscript Gelbkomponente  0.0252 g/l  0.0194 g/l  0.0114 g/l  0.022 g/l
             Result of the preliminary test: 0.0599 g/l

Remark: Increasing 1-octanol solubilities of the test item Bayscript Gelbkomponente between 0.0114 g/l (24hours, Flask 3) and 0.0252 g/l (72 hours, Flask 1) were observed. Therefore the mean value was calculated with the concentrations of Flask 1 and Flask 2.

Result of the preliminary test: 0.0599 g/l.

The determination of the 1-octanol solubility was based on Council Regulations EC No 440/2008, Guideline Part A – Methods for the Determination of the physical-chemical properties, A.6, “Water solubility” and to the OECD guideline for testing of chemicals No: 105 “Water solubility“.

Description of key information

The 1-octanol solubility of the test item Bayscript Gelbkomponente in 1-octanol determined by HPLC at 20 °C was:

 Test at 20 °C  Flask 1  Flask 2  Flask 3  Mean value of Flask 1 and Flask 2
 1 -Octanol solubility of Bayscript Gelbkomponente  0.0252 g/l  0.0194 g/l  0.0114 g/l  0.022 g/l
             Result of the preliminary test: 0.0599 g/l

Remark: Increasing 1-octanol solubilities of the test item Bayscript Gelbkomponente between 0.0114 g/l (24hours, Flask 3) and 0.0252 g/l (72 hours, Flask 1) were observed. Therefore the mean value was calculated with the concentrations of Flask 1 and Flask 2.

Result of the preliminary test: 0.0599 g/l.

The determination of the 1-octanol solubility was based on Council Regulations EC No 440/2008, Guideline Part A – Methods for the Determination of the physical-chemical properties, A.6, “Water solubility” and to the OECD guideline for testing of chemicals No: 105 “Water solubility“.

Key value for chemical safety assessment

At the temperature of:
20 °C
Solubility in organic solvents at 20°C:
0.022 g/L

Additional information

Solubility in 1-octanol