Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 May 2017 to 23 Aug 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline 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)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
White or off-white solid
Batch: 506001
Purity/Composition: 98%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
Test item storage: At room temperature
Stable under storage conditions until: 24 March 2018 (retest date)

Results and discussion

Water solubility
Key result
Water solubility:
2.55 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
ca. 7.2
Remarks on result:
other: Mean of the concentrations obtained at both flow rates
Details on results:
The coefficient of variation (CV) (n = 10) was ≤ 30% at both flow rates. It demonstrated that the system was equilibrated at all flow rates.
The maximum difference (MD) on the mean values of the samples at both flow rates was also ≤ 30%. Based on this, the water solubility of the test item is given as the mean value of these measurements.
The turbidity of the eluates was < 0.2 NTU. According to this, no undissolved particles were detected in the eluates.

Applicant's summary and conclusion

Conclusions:
This study validly assessed the solubility in water according to the specificied guidelines.The water solubility of the test item at 20°C was 2.55 mg/L.