Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 23 January 2017 to 16 March 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to other study
Remarks:
validated analytical method used for quantification of the water samples

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
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
solid: crystalline
Details on test material:
Appearance: white crystalline powder
Storage conditions: at room temperature protected from light

Results and discussion

Water solubility
Key result
Water solubility:
347 g/L
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
5.2
Details on results:
-Concentration analysed after 24, 48 and 72 hours of stirring: 366 g/L, 318 g/L and 356 g/L, resp.
-The mean of the three concentrations was reported as the water solubility of the substance.
-Maximum difference meets the criterion of ≤ 15% (i.e. 14%)

No test substance was detected in the pretreated sample from the blank.

Applicant's summary and conclusion

Conclusions:
The water solubility of the substance at 20°C was determined to be 347 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 5.2. From the measurements obtained after 24, 48 and 72 hours of stirring, the water solubility at 20°C was determined to be 347 g/L.