Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 21 January 2016 to 17 February 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
(EC 440/2008)
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): SAM-3
- Lot/batch No.: SAM-3/660-137/K1
- Material number: P60689-51
- Storage conditions: ambient temperature, dry, well ventilated area protected from sunlight.
Specific details on test material used for the study:
Substance was tested as received.

Results and discussion

Water solubility
Key result
Water solubility:
351.2 g/L
Temp.:
20 °C
pH:
>= 6.5 - <= 6.7
Remarks on result:
other: The study was performed at ambient temperature (not further specified).

Any other information on results incl. tables

Flask 1: 350.982 g/L

Flask 2: 352.809 g/L

Flask 3: 349.851 g/L

Because the maximum difference meets the criterion of ≤ 15%, the mean of the three concentrations was reported as the water solubility of the substance.

Applicant's summary and conclusion

Conclusions:
Using the flask method, the water solubility of the substance at ambient temperature has been determined as 351 g/L. The study was in accordance with EC A.6 and in compliance with GLP.