Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
6 December 1994 and 14 April 1995
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 the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
as below
Principles of method if other than guideline:
1) Alkane 2 was not tested for water solubility using the column elution method specified in Commission Directive 92/69/EEC as this method is unsuitable for use with liquid substances.

2) Due to the low water solubility of Alkane 2, it proved impractical to prepare samples at 5 times the saturation level. The test mixtures were prepared at approximately 50 times the saturation level.

These deviations have been considered not to have affected the integrity of the study.
GLP compliance:
yes (incl. QA statement)
Remarks:
The work described was performed in compliance with the UK Principles of Good Laboratory Practice (The United Kingdom Compliance Programme, Department of Health 1989).
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Water solubility:
< 0 g/L
Temp.:
19.5 °C
pH:
6.4

Any other information on results incl. tables

The preliminary test determined the water solubility to be 6E-4 g/L.

The peak areas relating to the standard and sample solutions are detailed below:

Solution  Mean peak area
Standard 24.5 mg/L 9.53E+04
Standard 25.5 mg/L 9.83E+04
Sample 1 <5.0E4
Sample 2 <5.0E4
Sample 3 <5.0E4

Sample number Time shaken at 30 deg C (hours) Time held at 20 deg C (hours) Concentration (g/l)
1 24 24 <1.3E-4
2 48 24 <1.3E-4
3 72 24 <1.3E-4

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The water solubility of Alkane 2 has been determined to be less than 1.3E-4 g/L of solution at temperature of 19.5 +/- 0.5 deg C.
Executive summary:

The peak areas of the pair of standards associated with a particular sample were corrected to nominal concentration and the mean value taken prior to the calculation of the sample concentration.

While there is evidence of the presence of test material in the analysed sample solutions, it is considered to be due to incomplete separation of excess sample from the saturated solvent; on this basis, the water solubility is expressed as a limit value which takes into account test material detected in the sample solutions.

With the exception of the following deviations, the experimental procedure used complied with that specified in Method A6 of Commission Directive 92/69/EEC (which constitutues Annex V of Council Directive 67/548/EEC):

1) Alkane 2 was not tested for water solubility using the column elution method specified in Commission Directive 92/69/EEC as this method is unsuitable for use with liquid substances.

2) Due to the low water solubility of Alkane 2, it proved impractical to prepare samples at 5 times the saturation level. The test mixtures were prepared at approximately 50 times the saturation level.

These deviations have been considered not to have affected the integrity of the study.

The water solubility of Alkane 2 has been determined to be less than 1.3E-4 g/L of solution at temperature of 19.5 +/- 0.5 deg C.