Diammonium 5-(hexylsulfonyl)-2-{[3-methyl-2,7-dioxo-1-(3-sulfonatobenzoyl)-2,7-dihydro-3H-naphtho[1,2,3-de]heterocycle-6-yl]amino}benzenesulfonate

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 January 2009 to 26 February 2009

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:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection: 19 August 2008; Date of signature: 04 March 2009

Type of method:

flask method

Test material

Test material information

Results and discussion

Water solubility

Water solubility:

28.4 - 30 other: % w/w

Temp.:

20 °C

pH:

4.8

Any other information on results incl. tables

Preliminary test

The preliminary estimate of water solubility was in the range 20.1 to 30.0 % w/w of solution.

Definitive test

Observations, concentrations and pH’s relating to the samples are shown in the following table:

Table 2

Sample	Concentration (% w/w)	Observations	pH
1	21.9	Non-viscous, single phase, deep red coloured solution with no excess undissolved test material visible.	5.0
2	24.0	Non-viscous, single phase, deep red coloured solution with no excess undissolved test material visible.	4.8
3	26.1	Non-viscous, single phase, deep red coloured solution with no excess undissolved test material visible.	4.8
4	28.4	Non-viscous, single phase, deep red coloured solution with no excess undissolved test material visible.	4.8
5	30.0	Two phase system, one being a non-viscous, deep red coloured solution, the other being a deep red coloured gelatinous semi-solid; small amount of excess test material also present.	4.8
6	31.9	Extremely viscous, deep red coloured semi-solid mass containing excess test material	*

*Too viscous for pH measurement

Overall result:In the range 28.4 to 30.0 % w/w of solution

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The water solubility of the test material has been determined to be in the range 28.4 to 30.0 % w/w of solution at 20.0 ± 0.5°C.

Executive summary:

In the range 28.4 to 30.0 % w/w of solution at 20.0 ± 0.5°C, using a procedure based on the flask method, Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008.