Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01 December 2008 to 10 March 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in compliance with agreed protocols with no deviations from standard test guidelines and/or minor methodological deficiences which do not affect the quality of the relevant results

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: dark red powder
- Lot/batch No.: MB-1A
- Storage condition of test material: room temperature in the dark

Results and discussion

Water solubility
Water solubility:
140 g/L
Temp.:
20 °C
pH:
ca. 5
Details on results:
It is evident from the information obtained in a hydrolysis studyconducted on teh substance and from data relating to the pH of the test material in water that negligible hydrolysis of the sample solution occurred during the course of the water solubility test.

Any other information on results incl. tables

 Sample Number Time Shaken at 30 C (hours)   Time Equilibrated at 20 C (hours)  Concentration (g/L)  Solution pH
 24  24.25  133  5.0
 48  24.25  143  5.0
 72  24.25  144  4.8

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): very soluble (> 10000 mg/L)
The water solubility of the substance has been determined to be 140 g/l of solution at 20.0±0.5°C in a study conducted to GLP in accordance with EU method A6. The substance is therefore regarded as being "very soluble"
Executive summary:

In a determination of general physico-chemical properties study (Harlan report 0959/0234) the water solubility of the substance has been determined to be 140 g/l of solution at 20.0±0.5°C in a study conducted to GLP in accordance with EU method A6. The substance is therefore regarded as being "very soluble".