Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 May 2008 and 02 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

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Water solubility:
44.7 g/L
Temp.:
20 °C
pH:
ca. 7.6

Any other information on results incl. tables

  Results

         Preliminary test

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

Sample

Concentration

(% w/w)

Observation

pH

1

1.0

Clear, colourless solution, with no excess, undissolved test material.

7.2

2

5.0

Clear, peach-coloured solution, with a slight excess of undissolved test material.

7.9

3

10.0

As for Sample 2, but more excess undissolved test material.

8.0

4

15.0

As for Sample 3, but more excess undissolved test material.

8.0

5

20.0

As for Sample 4, but more excess undissolved test material.

8.1

6

26.0

Much excess undissolved test material.

8.2

The preliminary estimate of water solubility was between 1.0 and 5.0 % w/w of solution.

            Definitive test

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

Solution

Absorbance

Standard 26.0 mg/l

0.90176

Standard 25.6 mg/l

0.85456

Matrix blank

None detected

Sample 1A

0.60598

Sample 1B

0.60448

Sample 2A

0.61680

Sample 2B

0.61065

Sample 3A

0.60404

Sample 3B

0.60876


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

44.4

7.7

2

48

24

45.1

7.6

3

72

24

44.5

7.6

Mean concentration:     44.7 g/l at 20.0 ± 0.5ºC
Range:                          44.4 to 45.1 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.

Conclusion

The water solubility of the test material has been determined to be 44.7 g/l of solution at 20.0 ± 0.5°C.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): soluble (1000-10000 mg/L)
The water solubility of the test material has been determined to be 44.7 g/l of solution at 20.0 ± 0.5°C.
Executive summary:

The determination 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 44.7 g/l of solution at 20.0 ± 0.5°C.