Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
yes
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Specific details on test material used for the study:
Batch number: 2015030121

Results and discussion

Water solubility
Water solubility:
0.057 g/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
7

Any other information on results incl. tables

 Results

 

Data in the tables are rounded values taken from Excel spreadsheets which will be archived together with the raw data. The use of Excel spreadsheets for calculations produces more accurate endpoints. These endpoints may slightly differ from the values derived by replacing the rounded values in the formulae are given in the methods section.

 

For all the sample solutions the pH value was 7.0, measured by pH meter.

The quality criteria of the A.6 method were verified (RSD% over three values is < 15%).

 

The summary values of temperature recorded during the test by the following instrument, are reported below.

Table7 Water Solubility: analytical results

 

Internal

code

As

Cs (1)

(mg/mL)

Ds

WaterSolubility

(g/L)

WS A

29735864

56.87

1

0.057

WS B

29532056

56.47

1

0.056

WS C

29381244

56.17

1

0.056

Mean value :

0.057

Standard deviation (S.D.) :

0.0003

Relative Standard Deviation (RSD%) :

0.62%

(1) Quantification with the linear calibration curve.

Applicant's summary and conclusion

Conclusions:
Water solubility of the substance is 0.057 g/L