Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-09-27 to 2007-04-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD Guideline 105 (Water Solubility) and EU Method A.6 (Water Solubility) without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Remarks:
The testing facility indicated that the protocol was followed without deviation.
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Remarks:
The testing facility indicated that the protocol was followed without deviation.
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
Department of Health of the Government of the United Kingdom
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): VRT-126016
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): not applicable
- Substance type: no data
- Physical state: white to off-white powder
- Analytical purity: 99.8 area% by High Performance Liquid Chromatography (HPLC)
- Impurities: chloride: <0.1%
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: 2006-02-02
- Lot/batch No.: 25719
- Expiration date of the lot/batch: February 2008
- Stability under test conditions: no data
- Storage condition of test material: at room temperature
- Other: no data

Results and discussion

Water solubility
Water solubility:
151 mg/L
Temp.:
20 °C
pH:
4.2
Details on results:
The detector calibration was found to be linear over the range 0 to 30 mg/L of standard solutions in the mobile phase with a regression coefficient of 1.0000. A mean recovery of fortified control samples of 100 % was deemed acceptable, and no correction was necessary for the determined sample concentrations. No significant interfering peaks were evident in blank control solutions.

Any other information on results incl. tables

Not applicable

Applicant's summary and conclusion

Conclusions:
The test substance was found to have a water solubility of 151 mg/L at 20 deg C.
Executive summary:

Not applicable