Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011-11-30 to 2011-12-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
, 1995
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
, 2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
, signed 2010-10-20
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Physical state: solid, whitish to white crystals
- Storage condition of test material: ambient temperature, dark, dry and in original container

Results and discussion

Water solubilityopen allclose all
Water solubility:
0.36 mg/L
Temp.:
20 °C
pH:
7
Remarks on result:
other: Deviation: 0.6 %
Water solubility:
0.53 mg/L
Temp.:
30 °C
pH:
7
Remarks on result:
other: Deviation: 7.8 %
Water solubility:
0.32 mg/L
Temp.:
10 °C
pH:
7
Remarks on result:
other: Deviation: 5.8 %

Any other information on results incl. tables

Solubility Results at 30 °C

Sample

Concentrations of test substance in [mg/L]

 

at 0.4 mL/min

at 0.2 mL/min

 

1

0.576

0.509

 

2

0.572

0.533

 

3

0.554

0.498

 

4

0.524

0.517

 

5

0.525

0.487

Overall

Mean

0.550

0.509

0.530

Deviation [%]

9.92*

9.45*

8.06**

SD

0.0250

0.0200

 

 

Solubility Results at 20 °C

Sample

Concentrations of test substance in [mg/L]

 

at 0.4 mL/min

at 0.2 mL/min

 

1

0.360

0.365

 

2

0.369

0.375

 

3

0.371

0.378

 

4

0.351

0.352

 

5

0.371

0.338

Overall

Mean

0.364

0.362

0.363

Deviation [%]

5.70*

11.83*

0.550**

SD

0.00900

0.0200

 

 

Solubility Results at 10 °C

Sample

Concentrations of test substance in [mg/L]

 

at 0.4 mL/min

at 0.2 mL/min

 

1

0.305

0.347

 

2

0.310

0.338

 

3

0.311

0.330

 

4

0.287

0.317

 

5

0.331

0.302

Overall

Mean

0.309

0.327

0.318

Deviation [%]

15.33*

14.90*

5.83**

SD

0.0160

0.0200

 

  

SD = Standard deviation

 

*) = Deviation of the successive test samples according to formula: Deviation = (cmax– cmin) x 100 / cmin

c = concentration of the test item

 

**) = Deviation between the runs according to formula:Deviation = (c1– c2) x 100 / c1

c1= concentration of the test item determined at the first flow rate

c2= concentration of the test item determined at the second flow rate

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
According to OECD Guideline 105 (1995) and Regulation (EC) No 440/2008 Method A.6., the water solubility of the substance is 0.36 mg/L at 20 °C/pH 7.