Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9.8.2017-30.8.2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

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
Guideline:
EU Method A.8 (Partition Coefficient - Shake Flask Method)
Deviations:
yes
Remarks:
Since the sample composition was complicated, it was not possible to determine all component concentrations by simple analytical methods. The concentrations were calculated by using gravimetric values of water and 2-octanol layers.
GLP compliance:
no
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Type of method:
flask method
Partition coefficient type:
octanol-water

Test material

Constituent 1
Reference substance name:
Active enzyme protein of β-Glucosidase (EC no. 232-589-7, CAS no. 9001-22-3, EC name: Glucosidase, β-, Enzyme Class no. 3.2.1.21)
Molecular formula:
Not available. See remarks.
IUPAC Name:
Active enzyme protein of β-Glucosidase (EC no. 232-589-7, CAS no. 9001-22-3, EC name: Glucosidase, β-, Enzyme Class no. 3.2.1.21)
Constituent 2
Reference substance name:
Proteins as constituents of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available. See remarks.
IUPAC Name:
Proteins as constituents of enzyme deriving from the fermentation or extraction process
Constituent 3
Reference substance name:
Carbohydrates as a constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available. See remarks.
IUPAC Name:
Carbohydrates as a constituent of enzyme deriving from the fermentation or extraction process
Constituent 4
Reference substance name:
Lipids as a constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available. See remarks.
IUPAC Name:
Lipids as a constituent of enzyme deriving from the fermentation or extraction process
Constituent 5
Reference substance name:
Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available. See remarks.
IUPAC Name:
Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
Test material form:
liquid
Details on test material:
- Substance type: UVCB
- Physical state: liquid
- Lot/batch No.: ABK172131381
- Storage conditions: cool below 10 degrees of Celsius
Specific details on test material used for the study:
- Substance type: UVCB
- Physical state: liquid
- Lot/batch No.: ABK172131381

Study design

Analytical method:
other: Gravimetry.

Results and discussion

Partition coefficient
Key result
Type:
log Pow
Partition coefficient:
0.02
Temp.:
21 °C
pH:
> 4 - <= 7

Applicant's summary and conclusion

Conclusions:
The partition constituent of water/2-octanol was determined by using the Shake Flash -method. Based on the results the Log Pow for the test item is 0.020.
Executive summary:

The partition constituent of water/2-octanol was determined by using the Shake Flash -method. Based on the results the Log Pow for the test item is 0.020.