Registration Dossier

Administrative data

Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
no

Study design

Analytical monitoring:
yes
Details on sampling:
Samples were taken and analysed at day 0, 1, 2, 3, 4 and 5
Buffers:
pH 4.0 Buffer Solution

164ml of 0.2M acetic acid solution was added to 36ml of 0.2M sodium acetate and diluted to 1 litre with distilled water.

pH 7.0 Buffer Solution

296ml of 0.1M sodium hydroxide solution was added to 500ml of 0.1M monopotassium phosphate solution and diluted to 1 litre with distilled water.

pH 9.0 Buffer Solution

213ml of 0.1M sodium hydroxide solution was added to 500ml of 0.1M boric acid in 0.1M potassium chloride and diluted to 1 litre with distilled water.

All buffer solutions were prepared in distilled water which was degassed with helium. The pH of each buffer solution was measured prior to use and adjusted if necessary.

Details on test conditions:
The tests were prepared in duplicate and the pH of each stable solution was measured prior to storage at 50 ±1ºC for up to 5 days.


Duration of test
Number of replicates:
All tests were conducted in duplicate.
Positive controls:
no
Negative controls:
no

Results and discussion

Transformation products:
not measured
Total recovery of test substance (in %)open allclose all
% Recovery:
>= 101.5 - <= 101.9
pH:
4
Temp.:
50 °C
Duration:
5 d
% Recovery:
>= 101.8 - <= 114.2
pH:
7
Temp.:
50 °C
Duration:
5 d
% Recovery:
>= 101.9 - <= 102.2
pH:
9
Temp.:
50 °C
Duration:
5 d

Any other information on results incl. tables

Less than 10% hydrolysis had occurred at all three pH's after 5 days storage at 50°C ± 1 deg C therefore, no further testing was carried out.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
At pH 4,7 and 9 there was less than 10% hydrolysis after 5 days storage at 50°C ± 1 deg C.