Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From September 28, 2010 to September 30, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted in compliance with international guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Results and discussion

Water solubility
Water solubility:
> 584 g/L
Temp.:
22 °C
pH:
1.2
Remarks on result:
other: Only a water solubility above a concentration has been determined (upper limit not reached in the test).
Details on results:
After mixing a total of about 5 g of the test item in 5 mL of water and stirring for 1, 2, 4, 6 and 24 hours, respectively, a dark purple solution was obtained. Based on visual judgment the test item was completely dissolved. The pH of the supernatant solutions was determined to be 1.15 after 1 hour, 1.26 after 2 hours, 1.26 after 4 hours, 1.26 after 6 hours and 1.27 after 24 hours. The water solubility of test item was determined at 22°C to be higher than 584 g/L. The aqueous solutions have been quantified by HPLC with respect to a calibration curve. The r² fit was 0.9993 (optimum 1.0000). This reflects the linearity of the HPLC-system within the calibration range of 3.49 μg/mL to 104.70 μg/mL of the test item.

Any other information on results incl. tables

Results of the Water Solubility:

Initial Weight of Test Item (g) Time (h) Water added (mL) Measured concentration (µg/L) Dilution factor Solubility in water (g/L) Mean (g/L)
5,2 1 5 61,65 10000 616,5 628,9
5,27 5 64,13 10000 641,3
5,24 2 5 61,44 10000 614,4 653,7
5,45 5 69,29 10000 692,9
5,35 4 5 64,18 10000 641,8 651,8
5,24 5 66,18 10000 661,8
5,27 6 5 64,95 10000 649,5 644,1
5,38 5 63,87 10000 638,7
5,08 24 5 57,23 10000 572,3 584,1
5,31 5 59,59 10000 595,9

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): very soluble (> 10000 mg/L)
Executive summary:

The determination of the water solubility of test item was performed according to the EEC Directive 92/69, A.6 “Water Solubility” (1992) and the OECD guideline No. 105, “Water Solubility” (adopted July 27, 1995), using a simplified flask method. After mixing a total of about 5 g of the test item in 5 mL of water and stirring for 1, 2, 4, 6 and 24 hours, respectively, a dark purple solution was obtained. Based on visual judgment the test item was completely dissolved. The pH of the supernatant solutions was determined to be 1.15 after 1 hour, 1.26 after 2 hours, 1.26 after 4 hours, 1.26 after 6 hours and 1.27 after 24 hours. The water solubility of test item was determined at 22°C to be higher than 584 g/L. The aqueous solutions have been quantified by HPLC with respect to a calibration curve.