Registration Dossier

Physical & Chemical properties

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:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EEC Directive 84/449/EEC, Annex V, Method A7.
Deviations:
yes
Remarks:
no analytical determination
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): P-#620

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.