Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 October 2010 - 26 October 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Water solubility:
< 0 g/L
Temp.:
20 °C
Remarks on result:
other: No pH value quoted in study report.
Details on results:
No pH value quoted in study report.
Most of the measured values are below the quantitation limit, 0.5 μg/ml; therefore calculation of the mean value is not feasible.
Considering the tenfold concentration of the samples before the analysis, the above results correspond to a water solubility of less than 5x10E-5 g/l at 20 °C ± 1°C.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The test material was found to have a water solubility of less than 5x10E-5 g/l at 20 °C ± 1 °C.
Executive summary:

In a water solubility study (10/095-345AN), the water solubility has been determined to be less than 5x10-5 g/l at 20 °C ± 1 °C by the column elution method based on EU Test Method A.6.