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Diss Factsheets

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: valid method (restrictions for low sulubility substances)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes
Type of method:
column elution method

Test material

Results and discussion

Water solubility
Water solubility:
< 0.1 mg/L
Temp.:
22 °C
Remarks on result:
other: no pH mentioned

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
Under the experimental conditions described, the water solubility of the test article was determined to be less than 0.1 mg/l.
Executive summary:

The solubility in water of a substance is the saturation mass concentration of the test article in water at a given temperature.

A preliminary test was realised with the test article to determine the method to be used. The solubility being less than 1 g/l. the column elution method was used.

A glass microcolumn connected to a recirculating thermostated pump was used. The test was carried out at 20'C.

Quantity of test article: about 50 mg

Solvent used: water for injection

Carrier material: purified sand

Temperature of the room: 22'C

The samples were analysed by spectrophotometry