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Physical & Chemical properties

Water solubility

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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