[No public or meaningful name is available]

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

according to Directive 92/69/EEC

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Version / remarks:

Directive 92/69/EEC, annex V, A.6.

GLP compliance:

yes

Type of method:

column elution method

Test material

Reference

Name:

Unnamed

Type:

Constituent

Results and discussion

Water solubility

Water solubility:

ca. 0.5 mg/L

Temp.:

20 °C

pH:

7.1

Remarks on result:

other: roughly estimated value; the true solubilty is probably much lower

Details on results:

The preliminary tests pointed out, that the solubility is below 1 mg/L. Therefore the column elution method should be applied. But due to the absence of any analytical method to detect the test substance in this very small quantity it was not possible to perform the study.
Thus, the visually observed solubility limits of the prelimiary tests are given as results. the colour of the used filters indicated, that in each performed test nearly the entire quantity of the test substance was retained on the surface of the filteres. Therefore, the true solubilty will be extremly below the roughly estimated results.

Any other information on results incl. tables

Table 1: individual results

quantity [mg]	solvent	total volume [mL]	time of equilibration [h]	observation	limit of solubilty [mg/L] at 20°C	pH
0.24	reagent water	250	2	In each experiment undissolved particles were observed	< 1.0	7.0
0.92		500	24		< 1.8	7.2
0.18		200	24		< 0.9	7.1
0.05		100	24		< 0.5	7.1
0.31	buffer pH 4	250	2		< 1.2	4.0
0.39	buffer pH 7	250	2		< 1.6	7.0
0.64	buffer pH 9	250	2		< 2.6	9.0

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results: the substance is almost insoluble in aqueous media