Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 Oct 2017 - 30 Nov 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:
2018
Report Date:
2018

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:
flask method

Test material

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

Results and discussion

Water solubilityopen allclose all
Key result
Water solubility:
8.31 g/L
Conc. based on:
other: anionic part of the test item
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
>= 6.3 - <= 6.4
Key result
Water solubility:
8.57 g/L
Conc. based on:
other: cationic part of the test item
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
>= 6.3 - <= 6.4
Details on results:
Anionic part of the test item:
-Concentration analysed after 24, 48 and 72 hours of stirring: 8.65 g/L, 8.09 g/L and 8.19 g/L, resp.
-Maximum difference meets the criterion of ≤ 15% (i.e. 6.7%)
-The mean of the three concentrations was reported as the water solubility of the anionic part of the substance.
Cationic part of the test item:
-Concentration analysed after 24, 48 and 72 hours of stirring: 8.87 g/L, 8.30 g/L and 8.55 g/L, resp.
-Maximum difference meets the criterion of ≤ 15% (i.e. 6.7%)
-The mean of the three concentrations was reported as the water solubility of the cationic part of the substance.

Applicant's summary and conclusion

Conclusions:
The water solubility at 20°C was determined to be 8.31 g/L for the anionic part and 8.57 g/L for the cationic part of the substance.
Executive summary:

The water solubility of the anionic and cationic part of the substance was determined using the flask method in a GLP study according to EC A.6, OECD 105 and OPPTS 830.7840. Quantification was performed by UPLC-UV. The pH of the aqueous samples was 6.3-6.4. From the measurements obtained after 24, 48 and 72 hours of stirring, the water solubility at 20°C was determined to be 8.31 g/L for the anionic part and 8.57 g/L for the cationic part of the substance.