Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 March-27 June 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study according to guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
(1995)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
(OJEU no. L142, May 31, 2008)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identification: Neosolue-Aqulio
Molecular formula: C20H36O8
Molecular weight: 404.5
CAS Number: 922165-31-9
Description: Clear colourless to very pale yellow liquid
Batch: TVI-714
Purity: 99.5% (GC)
Test substance storage: At room temperature in the dark
Stability under storage conditions: Stable
Expiry date: 07 October 2012 (Retest date)

Results and discussion

Water solubility
Water solubility:
51.1 g/L
Temp.:
20 °C
pH:
3.6
Details on results:
The maximum difference (MD) of the concentrations determined in the 24, 48 and 72 hour test samples was ≤ 15%. Based on this, the water solubility of the test substance is given as the mean value of the analysed concentrations.

No test substance was detected in the pre-treated samples from the blank water mixture.

Any other information on results incl. tables

The results for the samples taken at 24, 48 and 72 hours are given in theTable below. The first value is for the two times centrifuged samples and the second value for the three times centrifuged samples.

 

   Main study - water solubility of the test substance

Stirring time

[hours]

Analysed concentration
[g/l]

Mean

[g/l]

MD

[%]

pH

24

61.8(A)

51.1

4.2

3.6

 

51.6

 

 

3.6

48

49.7

 

 

3.6

 

51.8

 

 

3.6

72

50.9

 

 

3.6

 

 51.5

 

 

3.6 

 

 

 

(A)Considered to be an outlier according to Dixons-Q test, therefore excluded from calculations

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): very soluble (> 10000 mg/L)
Using the flask method, the water solubility of the test substance at 20°C was determined as 51.1 g/l. The pH of the aqueous samples was 3.6.