Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Jan 2018 to 18 May 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline 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:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Specific details on test material used for the study:
Batch: 02/16
Purity: 100%
Expiry date: 01 January 2021
Storage conditions: Room temperature in the dark

Results and discussion

Water solubility
Key result
Water solubility:
0.616 g/L
Conc. based on:
test mat.
Incubation duration:
50 h
Temp.:
20 °C
pH:
> 4.1 - < 4.5

Applicant's summary and conclusion

Conclusions:
The water solubility of the test item has been determined to be 0.616 g/L of solution at 20.0 ± 0.5 °C.