Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 August 2018 - 17 October 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient - Shake Flask Method)
Version / remarks:
2016
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 107 (Partition Coefficient (n-octanol / water), Shake Flask Method)
Version / remarks:
1995
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7550 (Partition Coefficient, n-octanol / H2O, Shake Flask Method)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes
Type of method:
flask method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Appearance: Brown viscous liquid
- Storage condition of test material: At room temperature

Study design

Analytical method:
high-performance liquid chromatography

Results and discussion

Partition coefficient
Key result
Type:
log Pow
Partition coefficient:
0.6
Temp.:
20 °C
pH:
ca. 6.4
Details on results:
- Concentration analysed in the stock solution was 1.16 g/L (corrected for purity).
- Nominal quantity of the substance in each test sample: 2.31 mg (corrected for purity).
- Recovery (range) for the test samples: 91% - 95%.
- The log Pow values were within the criterion range of ± 0.3 log units (see table below)

Any other information on results incl. tables

Table: Shake-flask results

Ratio
n-octanol : water [v:v]

Analyzed concentration

Pow

log Pow

pH

n-octanol
[g/L]

water
[g/L]

individual

mean

1:1

0.285

0.0774

3.7x100

3.8x100

0.6

6.4

 

0.287

0.0740

3.9x100

 

0.6

6.4

1:2

0.363

0.0935

3.9x100

3.9x100

0.6

6.4

 

0.352

0.0899

3.9x100

 

0.6

6.4

2:1

0.232

0.0622

3.7x100

3.7x100

0.6

6.4

 

0.238

0.0640

3.7x100

 

0.6

6.5

Mean

3.8x100

 

0.6

 

Standard deviation

1.0x10-1

 

 

 

reported concentrations are corrected for purity, thus reflect the concentration of the main constituent

Applicant's summary and conclusion

Conclusions:
The log Pow of the substance at neutral pH and and 20°C was determined to be 0.6.