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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:
24 October 1989 to 11 December 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
other: EU Directive 84/449/EEC Part A7
Deviations:
no
GLP compliance:
yes
Medium:
standard fat
Solubility:
< 0.01 mg/100 g solvent
Temp.:
37 °C
Test substance stable:
yes
Details on results:
Ca. 0.1 g of the test substance and ca. 25 g fat are used for every experiment.

Experiments no. 9 and 10 are repetitions of the experiments no. 7 and 8.
In the experiments 7 - 10 with a higher pre-saturation temperature and a longer stirring time a little fat solubility of the test substance could be recognized, which is however < 0.01 mg /100 g fat. Due io this little fat solubility in the experiments 7 -10 the experiments 1-8 were not repeated under changed conditions (a longer stirring time).

Experiment No.

Pre-saturation

Stirring time at 37⁰C (h)

Mass ratio dissolved test substance/fat (mg/100g)

Stirring time (h)

Temperature (⁰C)

1

2.5

30

3

n.d.

2

2.5

30

3

n.d.

3

2.5

30

27

n.d.

4

2.5

30

27

n.d.

5

2.5

50

3

n.d.

6

2.5

50

3

n.d.

7

2.5

50

27

<0.01

8

2.5

50

27

<0.01

9

2.5

50

27

<0.01

10

2.5

50

27

<0.01

n.d.=not detectable

Conclusions:
The fat solubility of the test substance is < 0.01 mg in 100 g fat at 37 ⁰C.
Executive summary:

The objective of this study was the determination of the fat solubility of the test substance according to guideline 84/449/EEC, A7: fat solubility, study conducted in compliance with GLP.

 

The liquid phase was separated from the residue by centrifugation at 37 °C, followed by filtration through a pre-heated filter (37 °C) (Millex SR, 0.5 uni). A weighed portion of the fat (ca. 14 g) was mixed with 30 ml hexane and three times extracted with 7 ml water. The aqueous phases were combined and filled up to a volume of 25 ml. The concentration of the test substance in this solution was determined via photospetrometry.

 

The fat solubility of the test substance is < 0.01 mg in 100 g fat at 37 ⁰C.

Description of key information

The fat solubility of the test substance is < 0.01 mg in 100 g fat at 37 ⁰C.

Key value for chemical safety assessment

Additional information

The objective of this study was the determination of the fat solubility of the test substance according to guideline 84/449/EEC, A7: fat solubility, study conducted in compliance with GLP.

 

The liquid phase was separated from the residue by centrifugation at 37 °C, followed by filtration through a pre-heated filter (37 °C) (Millex SR, 0.5 uni). A weighed portion of the fat (ca. 14 g) was mixed with 30 ml hexane and three times extracted with 7 ml water. The aqueous phases were combined and filled up to a volume of 25 ml. The concentration of the test substance in this solution was determined via photospetrometry.

 

The fat solubility of the test substance is< 0.01 mg in 100 g fat at 37 ⁰C.