Registration Dossier

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Study design

Analytical monitoring:
yes
Details on sampling:
Degradations in buffer solutions at pH=4.0, 7.0, 9.0.
Concentrations checked at T0-T0+2 hours - T0+5 days (50 °C).
Buffers:
pH 4.0-7.0-9.0
Details on test conditions:
The abiotic degradation of Menaphtacyan was estimated in a preliminary test. The determination was undertaken at three pH levels (pH 4.0, 7.0 and 9.0). The test was performed at 50.0 ± 1 C under sterile conditions and protected from light. The solution was analyzed by HPLC with UV detection at the start of the test and after 2.4 hours and 5 days.
Number of replicates:
duplicates.
Positive controls:
no
Negative controls:
no
Statistical methods:
--

Results and discussion

Preliminary study:
No significant variation of pH for any buffer and any time.
Test performance:
Hydrolysis < 10% after 5 days, at all tested pH.
Transformation products:
no
Details on hydrolysis and appearance of transformation product(s):
--
Other kinetic parameters:
--
Details on results:
--

Any other information on results incl. tables

--

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The substance Menaphtacyan can be considered as a hydrolytically stable item and its t 1/2 at 25 °C was to be considered to be more than 1 year.