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Physical & Chemical properties

Solubility in organic solvents / fat solubility

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Endpoint:
solubility in organic solvents / fat solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 Jan-28 Jun 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Also according to GLP
Qualifier:
according to guideline
Guideline:
other: EEC A.7 1984
Principles of method if other than guideline:
Flask-stirring method
GLP compliance:
yes
Medium:
standard fat
Solubility:
796.57 mg/100 g solvent
Temp.:
37 °C
Test substance stable:
yes

Analytical data : fat solubility

Test conditions

Duplicate

Integrated peak area

Mass of solution analysed (g)

Fat solubility

Hours at 37 °C

Temperature stirred for 1 hour (°C)

g/100 g fat solution (S1)

mg/100 g of fat (S)

Mean result each test

mg/100 g fat (S)

3

30

A

161545

0.09984

0.76440

770.29

780.35

3

30

B

172096

0.10361

0.78422

790.42

3

50

A

203006

0.11172

0.85669

864.09

907.34

3

50

B

208622

0.10443

0.94164

0.94164

23

30

A

160737

0.10127

0.74988

755.55

760.61

23

30

B

184030

0.11428

0.75984

765.66

23

50

A

186593

0.10169

0.86570

873.26

885.03

23

50

B

184303

0.09784

0.88882

896.79

68

30

A

170550

0.10762

0.74869

754.34

753.57

68

30

B

179621

0.11348

0.74718

752.80

68

50

A

178091

0.10174

0.82641

833.30

839.56

68

50

B

191766

0.10782

0.83874

845.83

Conclusions:
The fat solubility of the test item at 37 °C was determined to be 796.57 mg /100g fat.
Executive summary:

The fat solubility of the test item was determined according to EC A.7 method in compliance with GLP.  The fat solubility of the test item at 37 °C was determined to be 796.57 mg /100g fat.

Endpoint:
solubility in organic solvents / fat solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 April 2014-08 May 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Also according to GLP
Qualifier:
according to guideline
Guideline:
other: EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: OPPTS 830.7840 (Water solubility)
Deviations:
no
Principles of method if other than guideline:
The Flask method was used for the determination of the solubility in n-octanol.
GLP compliance:
yes
Medium:
n-octanol
Solubility:
1.75 g/L
Temp.:
20 °C
Remarks on result:
other: Mean of the concentrations analysed at t=24, 48 and 72 hours.
Test substance stable:
yes
Details on results:
Concentration analysed after 24, 48 and 72 hours of stirring: 1.79, 1.76 and 1.71 g/L, resp.
The maximum difference (MD) of the concentrations analysed was ≤ 15% (4.1% was calculated).
No test substance was detected in the pretreated sample from the blank n-octanol mixture.
Conclusions:
The n-octanol solubility of the substance at 20°C has been determined as 1.75 g/L.
Executive summary:

The n-octanol solubility of the test item was determined according to EC A.6 method and OECD test guideline 105 in compliance with GLP. Using the flask method, it was determined that the solubility of the test item in n-octanol is 1.75 g/L at 20 °C.

Description of key information

Solubility in standard fat: 796.57 mg/100 g fat at 37 °C
Octanol solubility: 1.75 g/L at 20°C

Key value for chemical safety assessment

Solubility in mg/100g standard fat:
796.57
At the temperature of:
37 °C
Solubility in organic solvents at 20°C:
1.75 g/L

Additional information

The fat solubility of the substance was determined according to EEC Method A.7 (1984). The flask-stirring method was applied. Furthermore, the solubility in octanol was examined using the flask method according to OECD 105 (Oudhoff, 2014). A solubility of 1.75 g/L was determined.