Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 May - 14 Jun 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
yes (incl. certificate)
Remarks:
Food and Consumer Product Safety Authority, Den Haag, The Netherlands
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): PM-5927
- Physical state:off-white powder
- Lot/batch No.:07-02
- Expiration date of the lot/batch:05.02.2008
- Storage condition of test material: at room temperature protected from light

Results and discussion

Water solubility
Water solubility:
ca. 0.53 g/L
Temp.:
20 °C
pH:
7.5

Any other information on results incl. tables

Results

Stirring time [hours]

Individual [g/L]

Mean [g/L]

 

24

0.448

0.452

7.4

24

0.456

48

0.531

0.536

7.5

48

0.541

72

0.523

0.524

7.5

72

0.526

Mean concentration obtained at 48 and 72 h stirring

 

0.530

 

The 24 h measurement was significantly lower than the 48 h and 72 h measurements (maximum difference > 15%). According to the guidelines, the water solubility of the test substance was given as the mean value of the 48 h and 72 h measurements. No test substance was detected in the pretreated samples from the blank water mixture. The flask method was chosen for the determination of the water solubility of PM-5927. The water solubility of the test substance at 20.0 °C ± 0.8 °C was 0.530 g/L. The pH of the aqueous samples after 48 and 72 hours stirring was 7.5.

Applicant's summary and conclusion