Registration Dossier
Registration Dossier
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EC number: 619-566-0 | CAS number: 848301-65-5
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- yes
- Principles of method if other than guideline:
- Due to the test material being a very complex mixture of hydrocarbons, and it also being essentially insoluble in water, analysis of the sample
solutions was performed monitoring the TOC content of the sample solutions only. The preliminary water solubility test indicated that the column
elution method should have been performed as the solubility was less than 1x10-2 g/l. However, due to the physical nature of the test material, it was not possible to use this method; experience has shown that liquid test materials coated onto glass beads cause these beads to adhere together
forming a plug within the column and thus preventing water circulation. - GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Safepharm Laboratories Limited
- Type of method:
- flask method
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Results and discussion
Water solubility
- Water solubility:
- < 1 mg/L
- Temp.:
- 20 °C
- pH:
- 7.1
Any other information on results incl. tables
see also attached full study report at "4.2 Melting Point" [ Attachment 6, page 17 -20]
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
water solubilty: less than 1 mg/l at 20.0 ± 0.5°C (monitoring the total organic carbon (TOC) content of the sample solutions)
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