Custom Yellow #2

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 February - 19 March, 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD and/or EC guidelines, and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Substance type: bright yellow powder
- Physical state: solid
- Stability under test conditions: stable up to 180°C; stable in water for at least 4 hours.
- Stability under storage conditions: stable
- Storage condition of test material: at room temperature in the dark

Results and discussion

Water solubility

Water solubility:

< 0.05 mg/L

Temp.:

20 °C

pH:

6.5

Details on results:

A small response of the test substance was found in the chromatogram of the water sample after two times centrifugation. No response in the water sample after three times centrifugation was obtained. The reason for detection of the small response in the two times centrifuged sample was most likely due to carry over from the analytical system or centrifugation method.

The response obtained was significantly below the calibration solution at 0.005 mg/l. Based on this it was concluded that the water solubility of the test substance at 20.0°C +/- 0.5°C is < 0.05 mg/l (i.e. below the limit of quantification (LOQ) of the analytical method). The pH of the aqueous sample was 6.5.

No further research on the determination of the water solubility was performed. To support the column elution method or flask method it is required that the analytical method is able to detect the test substance at the water solubility level. With the preliminary test it was found that the water solubility of the test substance is significantly lower than the LOQ level of the analytical method. The column elution method and flask method could therefore not be supported.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The response obtained in the chromatograms was significantly below the calibration solution at 0.005 mg/l. Based on this it was concluded that the water solubility of the test substance at 20.0°C +/- 0.5°C is < 0.05 mg/l (i.e. below the limit of quantification (LOQ) of the analytical method). The pH of the aqueous sample was 6.5.