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Diss Factsheets

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Testing was conducted between 14 February 2008 and 31 March 2008.
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:
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)). Date of inspection: 21/08/2007. Date of signature: 23/04/2008.
Type of method:
flask method

Test material

Constituent 1
Details on test material:
Sponsor's identification :Hatcol 1760
Description : clear colourless slightly viscous liquid
Purity : >99%
Date received : 04 February 2008
Storage conditions :room temperature, in the dark

Results and discussion

Water solubility
Water solubility:
< 0 g/L
Temp.:
20 °C
pH:
ca. 7.1

Any other information on results incl. tables

Preliminary test

The preliminary estimate of water solubility was <8.33 x 10-4 g/l.

Definitive test

The mean total peak area ratios relating to the standard and sample solutions are shown in the following table:

Solution

MeanArea Ratio

Standard 1.00 mg/l

7.857 x 10-2

Standard 2.50 mg/l

0.216

Standard 5.00 mg/l

0.504

Standard 5.14 mg/l

0.510

Standard 7.50 mg/l

0.878

Standard 10.0 mg/l

1.276

Standard Blank

0.000

Sample Blank

2.627 x 10-2

Sample 1A

7.458 x 10-2

Sample 1B

0.115

Sample 2A

0.221

Sample 2B

0.139

Sample 3A

0.151

Sample 3B

0.182

Standard 1.00 mg/l

0.129

Standard 2.50 mg/l

0.258

Standard 5.00 mg/l

0.622

Standard 5.14 mg/l

0.610

Standard 7.50 mg/l

1.053

Standard 10.0 mg/l

1.441

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

24¾

1.02 x 10-5

7.4

2

48

24¾

1.86 x 10-5

6.9

3

72

24¾

1.76 x 10-5

6.3

Overall concentration:         <1.86 x 10-5 g/l at 20.0 ± 0.5ºC


Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The water solubility of the test material has been determined to be <1.86 x 10-5 g/l of solution at 20.0 ± 0.5°C.
Executive summary:

Method

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).

Conclusion

The water solubility of the test material has been determined to be <1.86 x 10-5 g/l of solution at 20.0 ± 0.5°C.