Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 20 April 2018 to 14 June 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:
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:
liquid
Details on test material:
Appearance: Clear colourless to pale yellow liquid
Test item storage: In refrigerator (2-8°C)

Results and discussion

Water solubility
Key result
Water solubility:
6.21 g/L
Incubation duration:
24 h
Temp.:
20 °C
pH:
2.8
Remarks on result:
other: maximum concentration measured
Details on results:
The amount of dissolved test item decreased with the stirring time, possibly due to hydrolysis (not further investigated). Therefore the maximum concentration of test item measured, i.e. after 24 hours of stirring, was reported as the water solubility.

Any other information on results incl. tables

Results Flask method

Stirring time
[hours]

Analyzed concentration
[g/L]

pH

 

 

 

24

6.21

3.2

 

 

 

48

4.54

3.0

 

 

 

72

4.10 (1)

3.1

 

 

 

(1) 4.00 g/L after the additional centrifugation step.

Applicant's summary and conclusion

Conclusions:
The water solubility of the substance at 20°C was determined to be 6.21 g/L.
Executive summary:

The water solubility 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-MS. The pH of the aqueous samples was 3.0 -3.2. Quantitative analysis after 24, 48 and 72 h of stirring showed that the concentration decreased with stirring time (possibly due to hydrolysis). Therefore the maximum concentration of test item measured, i.e. after 24 hours of stirring, was reported as the water solubility at 20°C: 6.21 g/L.