Registration Dossier
Registration Dossier
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EC number: 412-300-2 | CAS number: 139504-68-0 AMBER CORE
Solubility in organic solvents / fat solubility
Administrative data
- Endpoint:
- solubility in organic solvents / fat solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-02-22 to 1992-05-22
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to an internationally recognised method, and under GLP. However, the test procedure was modified. Moreover, no certificate of analysis is provided (i.e. impurities not stated). Therefore full validation cannot apply.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 84/449/EEC, Annex V, Method A7.
- Deviations:
- yes
- Remarks:
- no analytical determination
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): P-#620
Constituent 1
Results and discussion
Solubility in organic solvents / fat solubilityopen allclose all
- Medium:
- standard fat
- Solubility:
- >= 95 other: %w/w
- Temp.:
- 37 °C
- Medium:
- standard fat
- Solubility:
- >= 1 902 000 mg/100 g solvent
- Temp.:
- 37 °C
- Remarks on result:
- other: based on sample preparation of 0.24964 g of standard fat + 4.74726 g of P-#620
- Test substance stable:
- yes
Any other information on results incl. tables
All the prepared mixtures were observed to form an homogeneous phase at 37°C.
Applicant's summary and conclusion
- Conclusions:
- Amber Core (P#620) was found to be miscible in all proportions with Standard Fat HB 307 at 37°C.
- Executive summary:
The fat solubility of the test substance Amber Core (P#620) was measured under GLP according to modified EU A7 guideline. Mixtures with Standard Fat HB 307 in various proportions were prepared at 37°C and observed for homogeneity.
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