Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
Directive 92/69/EEC, A.6 Simplified flask shaking method
GLP compliance:
yes
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Results and discussion

Water solubility
Water solubility:
574 000 mg/L
Temp.:
20 °C
pH:
ca. 4.89

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): very soluble (> 10000 mg/L)
In conclusion, the water volubility of ucb 22060 at room temperature was determined to be
574 g/1 (or above).
The water volubility was not corrected for the purity of the test item
Executive summary:

The determination of the water solubiiity of ucb 22060 was performed according to the EEC Directive 92/69, A.6 “Water Volubility” (1992) and the OECD guideline No. 105, “Water Volubility” (1995) using a simplified flask method. The saturation concentration of ucb 22060 at room temperature was estimated by a simplified flask method. After mixing about 5 g of test item with 5 ml water, a clear solution was obtained. The test item was completely dissolved. The water volubility of ucb 22060 is therefore higher as determined in the present study. The determination of the concentration in the above mentioned solution was confirmed by HPLC with respect to a calibration curve. A typical chromatogram of a standard solution is given in Figure 1. A typical chromatogram of a sample solution after incubation is given in Figure 2. The rz fit of the calibration during the determination of the water volubility was 0.9985 (optimum 1.0000). This reflects the linearity of the HPLC-system within the calibration range of 11.418 pg/ml to 95.15 pg/ml of the test item.