Registration Dossier

Physical & Chemical properties

Water solubility

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 December 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
GLP compliance:
yes (incl. certificate)
Type of method:
column elution method
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor and G316533
- Expiration date of the lot/batch: 25 March 2018
- Purity test date: 22 August 2017
Key result
Water solubility:
< 0.001 g/L
Conc. based on:
test mat.
Remarks on result:
not determinable
Remarks:
The solubility of the test material is below the Limit of Detection of the HPLC

For the preliminary estimation, the majority of the 1 mg sample did not dissolve after 10 minutes vigorous shaking, 35 minutes in the ultra-sonic bath and being left to stand for 4 hours. It is expected that the solubility of the test material is below the limit of detection of the HPLC system.

Conclusions:
Estimated water solubility is below 0.001 g/L. It is expected that the solubility of the test material is below the limit of detection of the HPLC system.

Description of key information

Estimated water solubility is below 0.001 g/L.  It is expected that the solubility of the test material is below the limit of detection of the HPLC system.

Key value for chemical safety assessment

Water solubility:
0.001 g/L

Additional information