Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 14 March 2017 to 21 July 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 (incl. certificate)
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: Pink powder
- Storage conditions: At room temperature

Results and discussion

Water solubility
Key result
Water solubility:
0.009 mg/L
Temp.:
20 °C
pH:
>= 6.4 - <= 7.7
Remarks on result:
other: average of two runs
Details on results:
Mean (n=9) concentration in the water samples obtained at the flowrate of 24 mL/h was 0.00958 mg/L. CV= 8.4%.
Mean (n=10) concentration in the water samples obtained at the flowrate of 12 mL/h was 0.00899 mg/L. CV= 4.7%.
The maximum difference on the mean values at both flow rates was ≤ 30% (i.e. 6.4%). Average of two runs: 0.00929 mg/L.

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

Applicant's summary and conclusion

Conclusions:
The water solubility of the substance at 20°C was determined to be 0.009 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-UV/Vis. The water solubility was calculated as the average of two runs (24 mL/h and 12 mL/h). The water solubility at 20°C was determined to be 0.009 mg/L. The pH of the aqueous samples was 6.4 - 7.7.