Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Physical & Chemical properties

Solubility in organic solvents / fat solubility

Currently viewing:

Administrative data

Link to relevant study record(s)

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
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.