[No public or meaningful name is available]

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 - 14 November 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Version / remarks:

1995

Deviations:

yes

Remarks:

see principles of method if other than guideline

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Version / remarks:

Regulation (EC) No 440/2008

Deviations:

yes

Remarks:

see principles of method if other than guideline

Principles of method if other than guideline:

Due to the high water solubility of the test item, the present study was conducted according to a modified TG OECD 105 design. Instead of equilibrating substantial amounts of test item (about five times in excess) with water by stirring over several days and subsequently separating the test item from the saturated solution, water was added in a stepwise procedure to a defined amount of test item until complete dissolution occurred.

GLP compliance:

yes (incl. QA statement)

Remarks:

determination of total phosphorus was performed by a third laboratory under the QA system ISO/IEC 17025 and is therefore excluded from the statement of GLP compliance

Type of method:

flask method

Test material

Test material information

Constituent 1

Reference substance name:

Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated

Molecular formula:

Molecular formula of the eponymous compound: C6H14O12P2

IUPAC Name:

Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated

Test material form:

solid

Details on test material:

Batch No.: 18224600

Results and discussion

Water solubility

Key result

Water solubility:

>= 882 g/L

Conc. based on:

test mat. (dissolved fraction)

Temp.:

22 °C

pH:

4

Details on results:

Preliminary test
The preliminary test indicated a water solubility of >1000 g/L, as ca. 0.1 g were completely dissolved in 0.1 mL of ultra-pure water.

Main test
The results are given in the table in "any other information on results". The water solubility was determined as the mean of the triplicate test assays analysed. As this method does not ensure complete saturation of the solution, it is given as minimum value in mass per volume of solution. The test is satisfactory, if the concentrations of the three vessels do not differ by more than 15%.

Any other information on results incl. tables

Analytical determinations:

Test vessel	pH	Determined total phosphorous concentrations (g/L)	Determined test concentrations (g/L)*
No. 1	4	104	884
No. 2	4	103	875
No. 3	4	105	888
		Overall Mean	882

*Using a total phosphorous content of 11.77%

The concentrations of the three vessels differed by 1% (validity criterion given by OECD is met).

Applicant's summary and conclusion

Conclusions:

The water solubility of Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermen-ted by Saccharomyces cerevisiae, concentrated, phosphorylated (CAS no. 944-754-7) was determined according to a modified TG OECD 105 design. The water solubility of the test item at 22°C was >=882 g/L. The pH of the aqueous samples was 4.

Executive summary:

The water solubility of the test item “Fructose-1,6-Diphosphate, raw: Glucose anaerobically fermented by Saccharomyces cerevisiae, concentrated, phosphorylated“ was determined according to a modified TG OECD 105 design. To this end, increasing volumes of water were added in a stepwise procedure, to approximately 1 g of the test item at 22 ± 2 °C until complete dissolution, which occurred after addition of 0.6 mL of ultra-pure water. The concentration of test item was subsequently determined by total phosphorous analysis.

The determined water solubility of the test item is >=882 g/L at pH 4 and at 22 °C.