3,5,8-Trioxa-4-phosphaundec-10-en-1-aminium, 4-hydroxy-N,N,N,10-tetramethyl-9-oxo-, inner salt, 4-oxide

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 and 07 December 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Version / remarks:

(flask method)

Deviations:

yes

Remarks:

Summary of deviation is in 'principles of method if other than guideline'

Principles of method if other than guideline:

The standard EEC A6 Method was not applicable due to the extremely high water solubility of the test material. It was therefore not possible to prepare samples at five times saturation level as specified in the guideline. Therefore a number of individual samples were prepared at increasing nominal concentrations and the solubility determined by visual assessment of the resulting solutions. Reduced shaking and equilibrium times were used as the sponsor indicated high concentrations, increased temperature and increased time, the test material can polymerise.

GLP compliance:

yes (incl. QA statement)

Remarks:

(Date of inspection: 21/08/2007 Date of signature: 15/10/2007)

Type of method:

flask method

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

417-560-0

EC Name:

-

Cas Number:

67881-98-5

Molecular formula:

C11H22NO6P

IUPAC Name:

trimethyl[2-({2-[(2-methylprop-2-enoyl)oxy]ethyl phosphonato}oxy)ethyl]azanium

Details on test material:

- Name of test material (as cited in study report): MPC
- Substance type: White powder
- Physical state: Solid
- Lot/batch No.:270103
- Storage condition of test material: at approximately 4°C, in the dark until 26th October and then over silica gel at approximately 4 °C in the dark.

Results and discussion

Water solubility

Water solubility:

>= 83 - <= 86 vol%

Temp.:

20 °C

pH:

>= 5.9 - <= 6.8

Details on results:

Solubility in the range 83.6 to 86.0% w/w ofsolution at 20.0 ± 0.5°C.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): other: extremely high water solubility (83.6% to 86.0% w/w of solution at 20.0 +/- 0.5°C)
The water solubility of the test material was determined to be in the range of 83.6% to 86.0% w/w of solution at 20.0 +/- 0.5°C.

Executive summary:

The water solubility was calculated using Method A6 of Commission Directive 92/69/EEC with the deviation in sample preparation. The water solubility was calculated to be 83.6% to 86% w/w of solution at 20.0 +/- 0.5°C by visual inspection.