Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 4 March 2009 and 29 May 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Recently conducted GLP compliant study using the most recent test methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): JKY-214
- Physical state: white solid
- Analytical purity: No information
- Lot/batch No.: Y002E
- Expiration date of the lot/batch: No information
- Stability under test conditions: No information. Assumed stable due to no data to the contrary
- Storage condition of test material: room temperature in the dark
- Other:

Results and discussion

Water solubility
Water solubility:
<= 0.027 mg/L
Temp.:
20 °C

Any other information on results incl. tables

The overall results are shown in the following table

 Determination Mean Concentration (g/l)  Standard Deviation 
0.000027  27.5%
0.00000796   20.4%
0.000000777   31.4%
0.00000176  57.2%
Overall  0.000027   -

The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 0 to 5.0x10-12 mg/l. This was satisfactory with a correlation coefficient of 0.997 being obtained.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The substance is considered insoluble in water as the water solubility was determined to be less than or equal to 0.027 mg/l
Executive summary:

The water solubility has been assessed using the column elution method according to EU method A6 in compliance with GLP. Using glass micro-columns plugged with glass wool, the water solubility was measured HLPC-MS to determine the concentration in solution in comparison with a sample solution of known concentration prepared in terahydrofuran : water (50:50 v/v). Measurements were recorded in duplicate, with two further tests undertaken to investigate the effect of flow rate on the water solubility. As flow rate was determined not to afect the result, the water solubility was determined to be 0.027mg/l at 20.0±0.5oC