Inositol phosphates

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 07, 2009 to May 13, 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted according to EU Method A.6 (Water Solubility). GLP compliance is claimed through compliance with UK Good Laboratory Practice standards [Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)].

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Test material

Test material information

Constituent 1

Reference substance name:

Inositol phosphates

EC Number:

700-206-7

Molecular formula:

As this substance is a UVCB substance and consists varying degree of components, a single molecular formula is not applicable

IUPAC Name:

Inositol phosphates

Constituent 2

Reference substance name:

Synthetic inositol phosphates

IUPAC Name:

Synthetic inositol phosphates

Details on test material:

- Name of test material (as cited in study report): Synthetic Inositol phosphates
- Physical state: Amber coloured liquid
- Lot/batch No.: 95816206JH-012
- Storage condition of test material: Room temperature in the dark

Results and discussion

Water solubility

Water solubility 1

Water solubility:

> 5.09 other: % w/w

Temp.:

20 °C

pH:

1.7

Water solubility 2

Water solubility:

> 50.2 other: % w/w

Temp.:

20 °C

pH:

1.1

Water solubility 3

Water solubility:

> 94.8 other: % w/w

Temp.:

20 °C

pH:

0.7

Details on results:

The water solubility of the test material was determined to be fully miscible in all proportions at 20.0 ± 0.5 °C by visual assessment. For details see 'Table 2'.

Any other information on results incl. tables

Table 2: Sample concentration, observations and solution pH, on completion of the 20°C equilibration period

Sample no.	Concentration (% w/w)	Observations	Solution pH
1	5.09	Clear colourless solution with no excess test material	1.7
2	50.2	Clear, extremely pale straw coloured solution with no excess test material	1.1
3	94.8	Clear, pale straw coloured solution with no excess test material	0.7

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): miscible
The test material was determined by visual assessment to be fully miscible in water in all proportions at 20.0 ± 0.5°C.

Executive summary:

A study was conducted to determine the water solubility of synthetic inositol phosphates based on the EU Method A.6 (Water Solubility) (flask method).

The test material (5, 50 & 95% w/w) was dissolved in double-distilled water in separate flasks by shaking for 24 h at 30°C and then equilibrated at 20°C for 24 h. Each sample was then visually assessed for dissolution of the test material.

The test material was determined to be fully miscible in all proportions at 20.0 ± 0.5°C.