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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

Constituent 1
Details on test material:
Sponsor's identification : H-MI ammonium salt
Description : dark red solid
Batch number : MB-1
Date received : 04 December 2008
Storage conditions : room temperature in the dark


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.

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