Registration Dossier
Registration Dossier
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EC number: 442-680-5 | CAS number: 443688-20-8
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 12th to November 7th, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- EU Directive 92/69/EEC
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
Test material
- Reference substance name:
- Red LF 6339
- IUPAC Name:
- Red LF 6339
Constituent 1
Results and discussion
Water solubility
- Water solubility:
- >= 170 000 mg/L
- Temp.:
- 20 °C
- Remarks on result:
- other: .
Applicant's summary and conclusion
- Conclusions:
- water solubility > 170 g/l.
- Executive summary:
The determination of the water solubility of the substance was performed according to the EEC Directive 92/69, A.6 "Water Solubility" (1992) and the OECD guideline No. 105, "Water Solubility'' (1995) using a simplified flask shake method. After mixing a total of about 7 g of test item with 25 ml of water, a dark-red, high viscous solution was obtained. It was scarily possible to decide by visual judgement if complete dissolution was achieved. The water solubility of the substance might therefore be higher as determined in the present study. The determination of the concentration in the above mentioned solution was confirmed by HPLC with respect to a calibration curve. A main test was not performed.
The linearity of the analytical method was proven in range to 1.25 r2 was 1.0000 (optimum).
In conclusion, the water solubility of the test item at room temperature was determined to be at least 170 g/1 (or above)
The water solubility was not corrected for the purity of the test item.
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