Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes
Type of method:
flask method

Test material

Constituent 1
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:040802#

Results and discussion

Water solubility
Key result
Water solubility:
831 g/L
Conc. based on:
test mat.
Incubation duration:
48 h
Temp.:
20 °C
pH:
6.84
Remarks on result:
completely miscible
Details on results:
In the case of the X330 sample number 1, this sample failed to crystallise after 24 hours at 20°C, despite being more concentrated than the other samples that did show signs of crystallisation. It is proposed that a degree of super saturation could have occurred.

Any other information on results incl. tables

 Sample number  Weight of X330 sample (g)  Weight of water added (g)
 5.005  3.009
 2  4.998  4.017
 3  5.011  5.030
 4  5.004  6.022

Applicant's summary and conclusion

Conclusions:
X330 is fully miscible to water.
Its water solubility was visually estimated at 831 g/L (Water Used : HPLC Water; pH of water : 6.84)
Executive summary:

X330 was tested according to the EU method A.6, following the flask method. The solubility of the test item was assessed by visual estimation to a value of 831 g/l. X330 is therefore considered as fully miscible to water.