Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 24 Oct 2017 to 27 Jan 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Cross-reference
Reason / purpose:
reference to other study

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Since the substance was expected to be miscible with water, a solubility test was performed first. After stirring the test item with water, the mixture was checked visually for any undissolved test material. Additionally, the water phase was analysed (cation). Based on the result (miscible with water) it was concluded that no guideline method (flask or column elution) needs to be conducted.
GLP compliance:
yes
Type of method:
other: miscibility test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Appearance: Light tan solid
- Storage conditions: At room temperature protected from light
Specific details on test material used for the study:
All solutions containing the test item were protected from light.

Results and discussion

Water solubility
Key result
Water solubility:
> 1 000 g/L
Temp.:
20 °C
pH:
2.3
Remarks on result:
completely miscible
Details on results:
After the stirring period, the test sample was clear and no undissolved test item was observed.
The content of cationic part of test item that was dissolved in water sample was 673 g/L.

Any other information on results incl. tables

Testing above 1000 g/L is technically not feasible.

Applicant's summary and conclusion

Conclusions:
The substance is completely miscible with water at 20°C . The water solubility at 20°C was concluded to be > 1000 g/L.
Executive summary:

In a GLP experiment, it was observed visually that the substance is completely miscible with water at a nominal concentration of 1220 g/L at 20°C and pH 2.3. The water solubility at 20°C was concluded to be > 1000 g/L. The content of cationic part of test item that was dissolved in water sample was 673 g/L.