Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
other: visual observation

Test material

Reference
Name:
Unnamed
Type:
Constituent
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.