Registration Dossier

Administrative data

water solubility
Data waiving:
study technically not feasible
Justification for data waiving:
Justification for type of information:
Preliminary tests for two analytical methods have been tested :
- a method development in HPLC-UV has been carried out and has not been conclusive (no observation of characteristic peaks)
- a method development in GC-FID has also been carried out. It only has been observed a massif in the chromatogram which should correspond to the mineral oil used as solvent in the product. The main active substances are not detected.
Finally no analytical method specific to the complex substance could have been developped. The lack of analytical method prevents to achieve the water solubility testing. The study is considered not feasible.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion