Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 October 2018 - 08 November 2018
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:
2019

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
2016
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: off-white to beige powder
- Test item storage: at room temperature

Results and discussion

Water solubility
Key result
Water solubility:
7.15 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
>= 7.2 - <= 7.3
Remarks on result:
other: average of two flow rates
Details on results:
Mean concentration in the water samples (n=10) obtained at the flowrate of 24 mL/h was 7.29 mg/L. CV = 3.6%.
Mean concentration in the water samples (n=10) obtained at the flowrate of 12 mL/h was 7.01 mg/L. CV = 3.3%.
The maximum difference on the mean values at both flow rates was ≤ 30% (i.e. 3.9%). Average of two flow rates: 7.15 mg/L.

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.

Any other information on results incl. tables

The turbidity of the eluates was < 0.2 NTU. According to this, no undissolved particles were detected in the eluates.

Small responses at the retention time of the test item were detected in the chromatograms of the pretreated samples from the blank column. The maximum contribution to the response in samples was 0.088%. It was considered to have no significant effect on the results of the test samples.

Applicant's summary and conclusion

Conclusions:
The water solubility of the substance at 20°C was determined to be 7.15 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 of the substance at 20°C was determined to be 7.15 mg/L (average of two two flow rates - 24 mL/h and 12 mL/h).

The coefficient of variation (CV) (n=10) was ≤ 30% at both flow rates.

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

The pH of the aqueous samples was 7.2 -7.3.