Custom Red #2

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 February 2009 - 08 May 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study has been performed according to OECD and 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:

OECD Guideline 105 (Water Solubility)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

other: visual observation

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Custom Red #2
- Substance type: violet powder
- Physical state: solid
- Purity test date: no data
- Lot/batch No.: C50APR0805D
- Expiration date of the lot/batch: 08 January 2011
- Stability under storage conditions: stable
- Storage condition of test material: at room temperature in the dark

Results and discussion

Water solubility

Water solubility:

< 1 mg/L

Temp.:

20 °C

pH:

6.7

Details on results:

Preliminary test: No response of the test substance was observed in the chromatogram of the water sample. Based on the response of the lowest calibration solution (i.e. < 1 mg/l) and the dilution factor of the sample it demonstrated that the water solubility of the test substance is < 2 mg/l. To demonstrate that the water solubility of the test substance is < 1 mg/l a visual test at 1 mg/l was carried out.

Main study - visual test: After the stirring period, undissolved test substance was observed in the test sample. From this, it was concluded that the water solubility of the test substance at 19.8°C +/- 0.6°C is < 1 mg/l. The pH of the aqueous sample was 6.7. The pH of the aqueous sample was determined 56 days after the test. Undissolved test substance particles were observed. The sample had a pH similar to water. It indicated that no test substance was dissolved in the aqueous sample. The result was therefore accepted.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
From visual observation it was concluded that the water solubility of the test substance at 19.8°C +/- 0.6°C is < 1 mg/l. The pH of the aqueous sample was 6.7.