Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
27.07.95
Deviations:
yes
Remarks:
Determination of results by observation
Principles of method if other than guideline:
The solubility was determined in two steps: a preliminary test and a main test. The quantity of test item necessary to saturate the desired volume of water was estimated from the preliminary test. Measurements were performed until equilibrium is reached.
GLP compliance:
no
Type of method:
other: observation

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Key result
Water solubility:
153 g/L
Conc. based on:
test mat.
Incubation duration:
3 h
Temp.:
23 °C
Remarks on result:
other: pH not available

Applicant's summary and conclusion

Conclusions:
Water solubility = 153 g/L at 23 °C
The study was performed according to OECD TG105 with deviations (no determination of pH, lacking information of individual results of the three flasks, no analytical method) and therefore reliability of Klimisch 2 has been assigned.
Executive summary:

The water solubility of the test material was determined experimentally in a non-GLP test according to OECD guideline 105. The water solubility of the test material is 153 g/L at 23 °C.