Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 March 2017 - 25 April 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to other study

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:
Physical appearance: white crystalline powder
Test item storage: In refrigerator (2-8°C)

Results and discussion

Water solubility
Key result
Water solubility:
22.8 µg/L
Conc. based on:
test mat.
Temp.:
19.9 °C
pH:
>= 8 - <= 8.1
Remarks on result:
other: average of two runs (maximum difference= 27%)
Details on results:
Mean concentration in the water samples (n=10) obtained at the flowrate of 25 mL/h was 25.8 μg/L. CV= 5.9%.
Mean concentration in the water samples (n=10) obtained at the flowrate of 12 mL/h was 19.7 μg/L. CV= 6.0%.

The coefficient of variation (CV) (n=10) was ≤ 30% at both flow rates. It demonstrated that the system was in equilibrium at all flow rates.

The maximum difference on the mean values at both flow rates was ≤ 30%.

Any other information on results incl. tables

No test substance was detected in the samples from the blank column.

Applicant's summary and conclusion

Conclusions:
The water solubility at 19.9°C was determined to be 22.8 μg/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 19.9°C was determined to be 22.8 μg/L. The pH of the aqueous samples was 8.0 -8.1.