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Diss Factsheets

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 May 2008 and 13 June 2008
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 not effect the quality of the 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)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
The work described was performed in compliance with UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)).
Type of method:
flask method

Test material

Results and discussion

Water solubility
Water solubility:
217 g/L
Temp.:
20 °C
pH:
ca. 7.8
Details on results:
The water solubility of the test material has been determined to be 217 g/l of solution at 20.0 ± 0.5°C.

Any other information on results incl. tables

Preliminary test

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

Sample

Concentration

(% w/w)

Observation

pH

1

9.1 (w/v)

No excess of test material.

6.5

2

20.0

Clear, colourless solution, with some test material undissolved.

7.1

3

39.9

As for Sample 2, but more test material undissolved.

7.1

4

60.0

As for Sample 3, but more test material undissolved.

7.6

5

79.6

Wet powder.

*

The preliminary estimate of water solubility was between 9.1% w/v and 20.0% w/w of solution.


* not measured due to the nature of the sample

Definitive test

The absorbances relating to the standard and sample solutions are shown in the following table:

Solution

Absorbance

Standard 25.3 mg/l

0.51712

Standard 25.4 mg/l

0.52246

Matrix blank

None detected

Sample 1A1

0.43865

Sample 1B1

0.44734

Sample 2A1

0.44346

Sample 2B1

0.44939

Sample 3A1

0.44681

Sample 3B1

0.45306

The concentration (g/l) of test material in the sample solutions is shown in the following table:

 

Sample Number

Time Shaken at

~ 30ºC (hours)

Time Equilibrated at 20ºC (hours)

Concentration (g/l)

Solution pH

1

24

24

216

7.1

2

48

24

217

7.8

3

72

24

219

7.5

Mean concentration:     217 g/l at 20.0 ± 0.5ºC
Range:                          216 to 219 g/L

Validation

The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of 0 to 50 mg/L.  This was satisfactory with a correlation coefficient of 1.00 being obtained.

Discussion

Due to the high saturation level noted in the preliminary test, it was not possible to prepare samples at five times the saturation level as recommended in the guideline. However, the samples did indicate excess undissolved test material.

Conclusion

The water solubility of the test material has been determined to be 217 g/L of solution at 20.0 ± 0.5°C.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): very soluble (> 10000 mg/L)
The water solubility of the test material has been determined to be 217 g/l of solution at 20.0 ± 0.5°C.
Executive summary:

The determination for substance NDS-Li in project number 1307 -0447 was carried out using the flask method, Method A6 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). The water solubility of the test material has been determined to be 217 g/l of solution at 20.0 ± 0.5°C.