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Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
yes
Remarks:
Concerning: Pre-Incubation Temperature for the Flask method; According to the Guideline: 30+- 1°C; Deviation to the Guideline: 30 +- 2°C; Reason for the Deviation: technical reason; Presumed Effect on the Study: none
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7860 (Water Solubility Generator Column Method)

Test material

Constituent 1
Chemical structure
Reference substance name:
Etilefrine
EC Number:
211-910-4
EC Name:
Etilefrine
Cas Number:
709-55-7
Molecular formula:
C10H15NO2
IUPAC Name:
3-[2-(ethylamino)-1-hydroxyethyl]phenol
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Name: Effortil-Rohbase
Batch No: 310
Aggregate State at RT: solid
Colour: white
Purity: >98%
Analysis: meldting point
Certificate of Analysis: 19.07.2000
Storage: in orgiginal container, at room temperature, in the dark

Results and discussion

Water solubility
Water solubility:
ca. 63.7 mg/L
Temp.:
20 °C
pH:
ca. 9.8
Remarks on result:
other: Mean Value: 63.7mg/L; standard deviation: 0.713 mg/L
Details on results:
Results of the Preliminary Test
The water solubility of Effortil-Rohbase was estimated to be lower than 0.1 g/L.

Results of the Main Test
The saturation concentration of Effortil-Rohbase was estimated using photometric method. The linearity of the analytical method was proved in the concentration range from 10 to 100mg test item/L. The regression coefficient was determined to be 0.9999.
Corresponding to the analysis the water solubility of the test item was calculated to be 63.7 mg/L.

The water solubility of Effortil-Rohbase was determined to be 63.7 mg/L at 20 °C +- 1°C using flask method for the performance of the main test.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The water solubility of Effortil-Rohbase was estimated to be lower than 0.1 g/L in a preliminary test.

The water solubility of Effortil-Rohbase was determined to be 63.7mg/L at 20 +- 1°C using the flask method for the performance of the main test.