Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 - 26 Feb 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
July 27, 1995
GLP compliance:
yes
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Key result
Water solubility:
1.29 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
ca. 6

Any other information on results incl. tables

Confirmation of equilibrium state

The concentration of test item in the eluting fraction was measured four times after the test water was flowed at 0.4 mL/min through the column for measurement of water solubility. It was judged from the following results that the concentration had reached equilibrium after 48.0 hours.

Sampling time (hour)

Concentration (mg/L)

Relative standard deviation (%)

45.0

1.24

 

46.0

1.46

3.32

47.0

1.37

48.0

1.43

 

Test results

Flow rate

pH

Water solubility (mg/L)

Standard deviation

Maximum difference (%)

Measurement

value

Average

Average of all values

0.4 mL/min

5.9

1.38

1.32

1.29

0.0445

12.5

5.9

1.28

6.0

1.29

6.0

1.34

6.0

1.30

0.2 mL/min

6.0

1.24

1.27

0.0674

6.0

1.21

5.9

1.38

6.0

1.25

6.0

1.25

 

Water solubility of test item: 1.29 mg/L at 20 °C (pH ca. 6.0)

It was judged that the test results were valid because the maximum difference of concentration was less than 30%.

Applicant's summary and conclusion