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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:
To be completed
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to
Guideline:
other: OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
- Test item: REACH substance = freeze-dried commercial product
- Analytical purity: 97.2%
- Purity test date: 08 March 2017
- Lot:bacth No.: WI6G16X07 after drying
- Expiration date of the lot/batch: 16 July 2018
- Appearance: Off-white to yellow crystals
- Storage: At room temperature
Key result
Medium:
n-octanol
Solubility:
587 g/L
Test substance stable:
yes

Preliminary test

The content of test item dissolved in the n-octanol sample was 138 g/L.

Main study

The results for the samples taken at 24, 48 and 72 hours are given in the table below.

Stirring time

[hours]

Analyzed concentration
[g/L]

Mean

[g/L]

Maximum difference
[%]

 

 

 

 

24

580

587

2.3

 

 

 

 

48

743

 

 

 

 

 

 

72

594

 

 

 

 

 

 

The 48-hour measurement was significantly higher than the 24- and 72- hour measurements (maximum difference > 15%). According to the guidelines, the octanol solubility of the test item was given as the mean value of the 24- and 72-hour measurements, i.e. 587 g/L. No test item was detected in the pretreated samples from the blank octanol mixture.

Conclusions:
The solubility in n-octanol of the test item was 587 g/L.
Executive summary:

The solubility in n-octanol of the test item (= REACH substance) was determined in a GLP-compliant study performed in accordance with standards equivalent or similar to EC A.8 method and OECD Guideline No. 105, using the flask method. The solubility in n-octanol of the test item was 587 g/L.

Description of key information

The solubility in n-octanol of the test item (= REACH substance) was determined in a GLP-compliant study performed in accordance with standards equivalent or similar to EC A.8 method and OECD Guideline No. 105, using the flask method. The solubility in n-octanol of the test item was 587 g/L.

Key value for chemical safety assessment

Solubility in organic solvents at 20°C:
587 g/L

Additional information

The solubility in n-octanol of the test item was determined in one GLP-compliant study performed in accordance with standard methods, without deviations. The study is considered as reliable (Klimisch 1) and is selected as a key study for the endpoint.