Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 2017 - Novemeber 2017
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:
EU Method A.6 (Water Solubility)
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Batch number: 80100005
Expiration date: 13 October 2018
Purity: 99.8%
Stored at Room temperature (nominally 15 to 25C), dark
Physical state/appearance: White solid

Results and discussion

Water solubility
Key result
Water solubility:
6.9 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
10 g/L
Incubation duration:
> 1 - < 3 d
Temp.:
20 °C
pH:
> 7.5 - < 7.9
Details on results:
The detector calibration was found to be linear over the range 0 to 200 mg/L with a regression coefficient of 0.9999. There is a measured solubility of 6.9 ± 0.3 g/L, details are given in Table 1 below. An acceptable mean recovery of approximately 94% of WS-23 from fortified samples was achieved.

Any other information on results incl. tables

Table 1: Measurement of water solubility at 20°C

 Sample Number Time (days)  Concentration (g/L)  Mean Concentration (g/L)  pH
 1A, 1B  6.95, 6.85  6.90  7.9, 7.7
 2A, 2B  2  7.03, 6.31  6.67  7.6, 7.5
 3A, 3B  3  7.06, 6.93  7.00  7.5, 7.5

Water solubility = 6.86 +- 0.28 g/L (RSD = 4.1%)

Applicant's summary and conclusion

Conclusions:
The water solubility of WS-23 was determined to be 6.9 g/L at 20°C following the flask method and using High Performance Liquid Chromatography (HPLC).
Executive summary:

The water solubility of WS-23 was determined to be 6.9 g/L at 20°C following the flask method and using High Performance Liquid Chromatography (HPLC).