Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 January 2016 - 06 June 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to other study
Remarks:
validated analytical method used for quantification of the water samples

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
2014
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: off-white powder
- Storage condition of test material: At room temperature

Results and discussion

Water solubilityopen allclose all
Water solubility:
0.657 mg/L
Temp.:
20 °C
pH:
6.2
Remarks on result:
other: Flowrate 24 mL/h. Mean of 10 samples. CV= 11%.
Water solubility:
0.715 mg/L
Temp.:
20 °C
pH:
6.3
Remarks on result:
other: Flowrate 12 mL/h. Mean of 10 samples. CV= 3.6%.
Key result
Water solubility:
0.686 mg/L
Temp.:
20 °C
pH:
>= 6.2 - <= 6.3
Remarks on result:
other: mean value (maximum difference= 8.5%)
Details on results:
The coefficient of variation (CV) (n=10) was ≤ 30% at both flow rates. It demonstrated that the system was equilibrated at all flow rates.

The maximum difference on the mean values at both flow rates was ≤ 30%. The water solubility of the substance is given as the mean value of these measurements: 0.686 mg/L.

Any other information on results incl. tables

Small responses at the retention time of the test item were found in the samples from the blank column at both flow rates. This was probably caused by carry-over since a higher response was found in the analytical blank.The maximum contribution to the samples at a flow rate of 24 mL/h was 0.2% and 0.5 % to the samples at a flow rate of 12 mL/h. It was considered that it has no significant effect on the results of the test samples.

Applicant's summary and conclusion

Conclusions:
The water solubility at 20°C was determined to be 0.686 mg/L.
Executive summary:

The water solubility of the substance was determined using the column elution method in a GLP study according to EC A.6, OECD 105 and OPPTS 830.7840.

Quantification was performed by UPLC-MS/MS. The water solubility at 20°C was determined to be 0.686 mg/L. The pH of the aqueous samples was 6.2 -6.3.