Registration Dossier

Diss Factsheets

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: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
451-510-9
EC Name:
-
Cas Number:
128446-33-3
Molecular formula:
C36H42O12(OH)18-y[(C3H6O)nOH]; y=1-10; n=1-4; y x n = 3,7 (average)
IUPAC Name:
Reaction products of .alpha.-cyclodextrin and methyloxirane
Details on test material:
Batch 63B001
Cavasol W6 HP
Specific details on test material used for the study:
Batch: 63B001

Results and discussion

Water solubility
Key result
Water solubility:
> 500 g/L
Conc. based on:
test mat.
Incubation duration:
24 h
Temp.:
23 °C
Remarks on result:
completely miscible
Remarks:
clear solution
Details on results:
Certain amounts of the test substance were mixed in glass bottles with deionized water. The exact amounts are summerized in a table (see below). The mixtures were stirred at room temperature (23 °C) and analysed for undissolved particles with unaided eyes.

Any other information on results incl. tables

Results:                    Batch:                       63B001

total amount of test substance [g]

total amount of distilled water [ml]

stirring time

[h]

clear solution

(yes/no)

approximate solubility [g/l]

20

30

24

Yes

> 667

25

25

24

Yes

> 1000

30

20

24

Yes

> 1500

35

15

24

Yes

> 2333

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): miscible
Water solubility: > 500g / l