Registration Dossier
Registration Dossier
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EC number: 435-990-7 | CAS number: 371921-34-5
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 15 to April 12, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- 1995
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- column elution method
Test material
- Reference substance name:
- Yellow 981
- IUPAC Name:
- Yellow 981
- Test material form:
- solid: particulate/powder
Constituent 1
Results and discussion
Water solubility
- Water solubility:
- < 0.3 mg/L
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- below LOQ
- Details on results:
- During the main test six samples have been analysed 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 69 hours. The quantification was performed by HPLC.
Only a very small peak of the test item could be detected in any of the eluate samples which was smaller than the peak of the smallest calibration point. The smallest calibration point is regarded as limit of quantification during this study.
Applicant's summary and conclusion
- Conclusions:
- Water solubility: < 0.3 mg/l at 20 °C.
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