Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

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.