Registration Dossier

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08.10.-08.11.2007.
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
Version / remarks:
Directive 92/69/EEC. Published in OJ No L 383 A, December 1992
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Study design

Buffers:
Buffer mixtures - Clark and Lubs
pH=4
Details on test conditions:
HPCE conditions:
Capillary: CE capillary (Agilent), 80 cm long, Eff.length 72 cm, ID 50 micrometres, extended light path
Temperature: 25 C
Running buffer: 5 mM 2-aminobenzimidazole/ 0.004 mM H2SO4 + 0.0008 mM HCl, pH=2.5
Voltage: 30 kV, positive
Detection: 275 nm, indirect UV (sample 400/40 nm, reference 275/10 nm)
Injection: hydrodynamic, 50 mbar * 40 s

Results and discussion

Preliminary study:
pH 4: Less than 10% of the test substance underwent the hydrolysis within a 5 days period at 50 ˚C. A half-life time of hydrolysis at 25 ˚C and pH 4 can be expected higher than 1 year.
pH 7: More than 10% of the test substance underwent the hydrolysis within a 5 days period at 50 ˚C but less than 50% hydrolysed in 2.4 hours. . A half-life time of hydrolysis at 50 ˚C and pH 7 was estimated to 2.8 hours.

pH 9: More than 50% of the test substance underwent the hydrolysis in 2.4 hours. A half-life time of hydrolysis at 50 ˚C and pH 9 was estimated to 1.3 hours. A half-life time of hydrolysis at 25 ˚C can be expected lower than 1 day
Transformation products:
not specified
Dissipation DT50 of parent compoundopen allclose all
pH:
4
Temp.:
25 °C
DT50:
> 8 760 h
pH:
7
Temp.:
50
DT50:
ca. 67.2 h
pH:
9
Temp.:
25 °C
DT50:
< 24 h
pH:
9
Temp.:
50 °C
DT50:
1.3 h

Applicant's summary and conclusion