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)
Qualifier:
according to
Guideline:
other: CIPAC MT 157
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: 2016110462

Results and discussion

Water solubility
Water solubility:
0.07 g/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
5.4

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 5.4, measured by pH meter.

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

Table7 Water Solubility: analytical results

 

Internal

code

As

Cs (1)

(mg/mL)

Ds

WaterSolubility

(g/L)

WS A

110158

68.96

1

0.070

WS B

112784

70.63

1

0.071

WS C

114915

71.97

1

0.072

Mean value :

0.07

Standard deviation (S.D.) :

0.002

Relative Standard Deviation (RSD%) :

2.14%

(1) Quantification with the linear calibration curve.

Applicant's summary and conclusion

Conclusions:
Water solubility of the substance is 0.07 g/L