Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
yes
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Purity : 95.9 % w/w

Results and discussion

Water solubilityopen allclose all
Water solubility:
2.34 mg/L
Conc. based on:
other: ar 12.5 mL/h
Temp.:
20 °C
Remarks on result:
other: pH not available
Water solubility:
3.89 mg/L
Conc. based on:
other: 25 mL/h
Temp.:
20 °C
Remarks on result:
other: pH not available
Key result
Water solubility:
3.12 mg/L
Conc. based on:
other: average value
Temp.:
20 °C
Remarks on result:
other: pH not available
Details on results:
The test was performed at 20°C using water analytical grade.
Taking into consideration the functional groups in the molecular structure, it's reasonable to conclude that a change in the temperature or pH value give not a significant variation on the water solubility value.

Applicant's summary and conclusion

Conclusions:
Taking into consideration the functional groups in the molecular structure, it's reasonable to conclude that a change in the temperature or pH value give not a significant variation on the water solubility value.
At 25 mL/h = 3.89 mg/l with a RSD% of 13.0% over 16 fractions
At 12.5 mL/h = 2.34 mg/l with a RSD% of 13.4% over 16 fractions