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Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 19, 2001 till August 08, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to OECD Guideline 105 (Water Solubility) under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identity: ZP-TIX 1014
Batch: NW-01-028
Purity > 99%,
Appearance: Solid
Expiration date: 30.12.2001
Storage: At room temperature at about 20°C

The test item consits of three components. For the quantification the peak area sum of these three components was used.

Results and discussion

Water solubility
Water solubility:
< 0.9 mg/L
Temp.:
20 °C
pH:
ca. 7
Details on results:
During the preliminary test the water solubility of ZP-TIX 1014 at room temperature was estimated by a simplified flask method to be lower than the smallest calibration point of 0.9436µg/ml. Therefore, the column elution method was used for the performance of the main test.

During the main test six samples have been analysed in the first run (0.52 ml/min) and six samples during the second run (0.26 ml/min), each with a sampling intervalof one hour. Total elution time was 97.5 hours. The quantification was performed by HPLC. The measured results differ by less than 30%. Therefore the sutdy is considered to be valid.
The test item could not be detected in any of the eluated samples.

In conclusion, the water solubility of ZP-TIX 1014 at 20°C +/- 0.5 °C was determined to be below the smallest calibration point which is < 0.9 mg/l.

Any other information on results incl. tables

Experiment No. Flow rate [ml/h] Sample No. Concentration analysed [µg/ml]  Water solubility calculated [mg/l] pH
1 31 1 < 0.9436 < 0.9436 * 7
2 < 0.9436 7
3 < 0.9436 7
4 < 0.9436 7
5 < 0.9436 7
6 < 0.9436 7
2 16 7 < 0.9436 7
8 < 0.9436 7
9 < 0.9436 7
10 < 0.9436 7
11 < 0.9436 7
12 < 0.9436 7

* The measured concentration is below the smalles calibration point of 0.9436 mg/ ml

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
In conclusion, the water solubility of ZP-TIX 1014 at 20°C ± 0.5 °C was determined to be below the smallest calibration point which is < 0.9 mg/L using the column elution method.
Executive summary:

The determination of the water solubility of ZP- TIX 1014 was performed according to the EEC Directive 92/69, A.6 'Water Solubility" (1992) and the OECD guideline No. 105, 'Water Solubility" (adopted July 27, 1995).

During the preliminary test the water solubility of ZP- TIX 1014 at room temperature was estimated by a simplified flask method to be lower than the smallest calibration point of 0.9436 pg/mL. Therefore, the column elution method was used for the performance of the main test.

During the main test six samples have been analysed in the first run (0.52 mL/min) and six samples during the second run (0.26 mL/min), each with a sampling interval of one hour. Total elution time was 97.5 hours. The quantification was performed by HPLC. The measured results differ by less than 30 %. Therefore the study is considered to be valid.

The test item could not be detected in any of the eluate samples.