Registration Dossier

Physical & Chemical properties

Solubility in organic solvents / fat solubility

Administrative data

Endpoint:
solubility in organic solvents / fat solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: OECD Guideline 105
Deviations:
yes
Remarks:
OECD Guideline 105 is a water solubility test. To determine the solubility of the substance in octanol, a similar protocol was used using octanol as the solvent.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Mitsubishi-Chemical Food Corporation;

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in refrigerator

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: pulverized

Results and discussion

Solubility in organic solvents / fat solubility
Key result
Medium:
n-octanol
Solubility:
>= 1 000 g/L
Temp.:
20 °C
Remarks on result:
other: miscible in octanol
Test substance stable:
not determined
Details on results:
The pre-test solubility was incorrect as the test substance dissolution kinetics were slower than foreseen.
No precipitation was seen even after 10 g of test substance had been added. The solution became very viscous and could no longer be stirred.

Applicant's summary and conclusion

Conclusions:
The test substance is completely miscible in octanol.
Executive summary:

The solubility of the test substance was determined in a study performed similarly to a OECD Guideline 105 water solubility study, but octanol was used as the solvent. Up to 10 g of test substance was added to 10 mL of water. The liquid became very viscous, but no precipitate was observed. The solubility of the test substance in octanol is at least 1 kg/L octanol. The test substance is completely miscible in octanol at 20 degrees C.