Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 29, 2013 - November 7, 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed in accordance with the EC A.6 and OECD 105 guidelines and complied with the principles of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
(2008)
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:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): KF-1622
- Description: Clear colourless liquid
- Storage condition of test material: In refrigerator (2-8°C) in the dark
- Expiration date of the lot/batch: May 17, 2014

Results and discussion

Water solubilityopen allclose all
Water solubility:
0.015 mg/L
Temp.:
20 °C
pH:
6.9
Remarks on result:
other: Flowrate 24 mL/h. Mean of 10 samples. CV= 38%
Water solubility:
0.015 mg/L
Temp.:
20 °C
pH:
7
Remarks on result:
other: Flowrate 12 mL/h. Mean of 10 samples. CV= 6.4%.
Details on results:
The coefficient of variation (CV) (n = 10) at a flow rate of 24 mL/h and 12 mL/h was 38% and 6.1%, respectively. The criterion that coefficient of variation of at least five samples at each flow rate should be ≤ 30% was therefore not met. A second criterion that mean values obtained from two tests with different flows should not differ by more than 30% is considered more important. Since this criterion was met (difference was 3.3%), the results were accepted and the mean was reported as the water solubility of the substance: 15 µg/L.

Any other information on results incl. tables

- No test substance was detected in the samples from the blank column.

- Results for the first disregarded study:

Flowrate 24 mL/h: 0.0129 mg/L

Flowrate 12 mL/h: 0.0212 mg/L

Mean: 0.017 mg/L

(Flow rate 6 mL/h: no test substance detected)

The maximum difference (MD) on the mean values: 49%

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The water solubility of the substance at 20°C has been determined as 15 µg/L using the column elution method (GLP-compliant study in accordance with EC A.6, OECD 105 and OPPTS 830.7840). The pH was 6.9-7.0.