C-M5

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Testing was conducted between 28 March 2007 and 28 April 2007.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do no effect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

yes

Remarks:

See prinicples of method

Principles of method if other than guideline:

The standard A6 Method was not applicable to this test material due to the high indeterminable saturation levels produced. It was therefore not possible to prepare samples at five times the saturation level as recommended in the guideline. No analysis could be performed due to the high solubility producing unfilterable mixtures and thus the water solubility was estimated based on visual inspection.

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Results and discussion

Water solubility

Water solubility:

>= 38 - <= 39 other: %w/w

Temp.:

20 °C

pH:

>= 7.6 - <= 8.2

Details on results:

water solubility in the range 38.0 to 39.0% w/w at 20.0 ± 0.5ºC.

Any other information on results incl. tables

Results

Preliminary test

Observations, concentrations and pH's relating to the samples are shown in the following table.

Sample	Concentration (% w/w)	Observations	pH
1	30.0	Extremely dark purple coloured solution, no excess test material was present.	5.8
2	35.0	As for Sample 1, but more viscous.	5.6
3	40.0	As for Sample 2, but undissolved test material was present.	*
4	50.0	Much undissolved test material present.	*

The preliminary test indicated the water solubility of the test material was in the range 35.0 to 40.0% w/w.

Definitive test

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

Sample	Concentration (% w/w)	Observations	pH
5	36.0	Extremely dark purple coloured solution, no excess test material was present.	8.2
6	37.0	Extremely dark purple coloured solution, no excess test material was present.	7.7
7	38.0	Extremely dark purple coloured solution, no excess test material was present.	7.6
8	39.0	As for Samples 5 to 7, but undissolved test material present.	7.7

Result:  water solubility in the range 38.0 to 39.0% w/w at 20.0 ± 0.5ºC.

Discussion

The standard A6 Method was not applicable to this test material due to the high indeterminable saturation levels produced.  It was therefore not possible to prepare samples at five times the saturation level as recommended in the guideline.  No analysis could be performed due to the high solubility producing unfilterable mixtures and thus the water solubility was estimated based on visual inspection.

Conclusion

The water solubility of the test material has been determined to be between 38.0 and 39.0% w/w of solution at 20.0 ± 0.5°C.

* unable to record the pH due to the composition of the samples

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): miscible
The water solubility of the test material has been determined to be between 38.0 and 39.0% w/w of solution at 20.0 ± 0.5°C.

Executive summary:

The determination of substance CM-5 in project number 0345 -0889 was carried out using a flask method, based on Method A6 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC), Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995. The water solubility of the test material has been determined to be between 38.0 and 39.0% w/w of solution at 20.0 ± 0.5°C.

The standard A6 Method was not applicable to this test material due to the high indeterminable saturation levels produced.  It was therefore not possible to prepare samples at five times the saturation level as recommended in the guideline.  No analysis could be performed due to the high solubility producing unfilterable mixtures and thus the water solubility was estimated based on visual inspection.