N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)benzenesulphonamide

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: EEC Directive 92/69, A.6 "Water Solubility" (1992)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

column elution method

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 09979EB5
- Expiration date of the lot/batch: March 14,2011

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature at about 20

Water solubility:

< 0.254 µg/L

Conc. based on:

test mat.

Temp.:

20 °C

Remarks on result:

other: pH not specified

During the preliminary test the water solubility of FAT 36034/0 at room temperature was estimated by a simplified flask method to be lower than the smallest calibration point of 0.7416 ug/mL. Therefore, the column elution method was used for the performance ofthe main test.

During the main test six samples have been analyzed 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 93 hours. The sample measurement was performed by HPLC. The test item could not be detected in any of the eluate samples. The r2 fit was 0.9999 (optimum 1.0000). This reftects the linearity of the HPLC-system within the calibration range of 0.25368 ug/mL to 50.736 ug/L of the test item.

During this study the water solubility and the paltition coefficient of FAT 36034/G were determined. The water solubility of FAT 36034/0 at 20 °C was determined to be <0.254 ug/L.

Conclusions:

The water solubility of FAT 36034/G was calculated and found to be <0.254 µg/L (0.000254 mg / L)

Executive summary:

In a GLP compliant OECD 105 guideline study the water solubility of FAT 36034/G was determined using the column elution method. The concentration of FAT 36034/G in the samples was determined by HPLC measurement. During the main test six samples have been analyzed 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 93 hours. The sample measurement was performed by HPLC. The test item could not be detected in any of the eluate samples. The r2 fit was 0.9999 (optimum 1.0000). This reftects the linearity of the HPLC-system within the calibration range of 0.25368 ug/mL to 50.736 ug/L of the test item. The water solubility of the test item was calculated and found to be <0.254 µg/L.

Description of key information

Based on a GLP-compliant OECD 105 guideline key study (2008) the water solubility of FAT 36034/G was determined using the column elution method. The concentration of FAT 36034/G in the samples was determined by HPLC measurement. The water solubility of FAT 36034/G was determined to <0.254 µg/L. Whereas another study performed according to OECD 105 ( 2015) the water solubility of FAT 36034/H at a temperature of 20 °C using flask method was reported 1.8 mg/l.

Key value for chemical safety assessment

Water solubility:

0.254 µg/L

at the temperature of:

20 °C