Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 25 April 2016 to 15 May 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:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: yellow/brown powder
- Storage conditions: in refrigerator (2-8°C)

Results and discussion

Water solubility
Key result
Water solubility:
27.5 g/L
Incubation duration:
>= 48 - <= 72 h
Temp.:
20.1 °C
pH:
5.8
Details on results:

Concentration analysed after 24, 48 and 72 hours of stirring was 33.7 g/L, 28.1 g/L and 26.9 g/L, resp.

The 24-hour measurement was significantly higher than the 48- and 72- hour measurements (maximum difference > 15%). Therefore, the water solubility of the test item was given as the mean value of the 48- and 72-hour measurements (maximum difference of 4.4%).

Applicant's summary and conclusion

Conclusions:
The water solubility of the substance at 20°C was determined to be 27.5 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-MS. The pH of the aqueous samples at all sampling times was 5.8. From the measurements obtained after 48 and 72 hours of stirring, the water solubility at 20°C was determined to be 27.5 g/L.