Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP- and Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
GLP compliance:
yes (incl. QA statement)
Type of method:
column elution method

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
see confidential details

Results and discussion

Water solubility
Water solubility:
< 0.04 mg/L
Temp.:
20 °C
pH:
6.8

Any other information on results incl. tables

The solubility CS of the test substance in distilled water was determined according to the European Commission Council Regulation (EC) No 440/2008, Annex, Part A, A.6., OECD-Guideline 105 and EPA Product Properties Test Guideline OCSPP 830.7840, using the column elution method. The concentration of the test item was determined by HPLC analysis. The reversed phase HPLC

method used was found to be valid.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): insoluble (< 0.1 mg/L)