Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
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 (incl. certificate)
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Batch:102Z5
Purity: 99.9%
white powder
Specific details on test material used for the study:
Batch: 102Z5
Purity: 99.9%

Results and discussion

Water solubility
Key result
Water solubility:
ca. 0.004 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
0.102 g/L
Incubation duration:
ca. 125 h
Temp.:
20 °C
pH:
>= 6.2 - <= 6.3
Details on results:
See Table 1

Any other information on results incl. tables

Table 1. Overall results of water solubility

 System Mean Concentration (g/L)   Standard Deviation
 A 4.63 x 10e-3  1.43 x 10e-4 
 B  4.24 x 10e-3  6.35 x 10e-5

Applicant's summary and conclusion

Conclusions:
The water solubility of the test item has been determined to be 4.44 x 10e-3 g/L of solution at 20.0 ± 0.5 °C.