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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
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: OECD 105
Principles of method if other than guideline:
taking n-octanol as solvent.
GLP compliance:
no
Key result
Medium:
n-octanol
Solubility:
< 50 mg/L
Temp.:
20 °C
Test substance stable:
yes

Following results were obtained: 

 

Incubation time
(h)

Weighted sample (mg)

Concentration
(mg/L)

24

30.46

1.6

48

30.30

2.6

72

30.19

12.1

 

 

Nominal saturation concentration (g/L): about 0.3 g/L

 

The result given in the table were approved by independent determinations in duplicate.

 

After a measurement period of 72 hours no concentration plateau was reached. So the data of the preliminary tests were consulted in order to evaluate the solubility of the sample in n-Octanol.

The samples were weighted into vials and n-Octanol was added according the table. Then it was stirred for 30 min at room temperature and visually examinated. After 24 h at room temperature and no stirring the optical evaluation was performed.

 

 

Weighted sample
(mg)

n-Octanol
(mL)

Concentration (mg/L)

Optical Evaluation

0.7

30

23

clear solution

0.6

20

30

clear solution

0.67

10

67

cloudy solution

0.75

4

187

cloudy solution

 

Based on the results the n-Octanol solubility of the test item can be estimated to be < 50 mg/L.

 

Conclusions:
The octanol solubility at 20°C was determined to be < 50 mg/L.
Executive summary:

In the non-GLP Kllimisch 1 study from Frischmann (2013) the octanol solubility of Reaction products of ricinoleic acid with 2-aminoethanol and maleic acid and sodium hydrogensulfite was determined following the method as outlined in the OECD 105. Instead of water, octanol was used. The octanol solubility at 20°C was determined to be < 50 mg/L.

This value is considered relevant an reliable for the risk assessment. For the risk assessment, the n-octanol solubility of 50 mg/L will be used.

Description of key information

n-octanol solubility (20°C):  50 mg/L 

Key value for chemical safety assessment

Additional information

In the non-GLP Kllimisch 1 study from Frischmann (2013) the octanol solubility of Reaction products of ricinoleic acid with 2-aminoethanol and maleic acid and sodium hydrogensulfitewas determined following the method as outlined in the OECD 105. Instead of water, octanol was used. The octanol solubility at 20°C was determined to be < 50 mg/L.

This value is considered relevant an reliable for the risk assessment. For the risk assessment, the n-octanol solubility of 50 mg/L will be used.