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: GLP study, OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
2007-10-15

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
description: yellow solid gel
batch number: 1484JG
Received: 2008-04-07
Storage conditions: room temperature in the dark

Study design

Buffers:
Specification of buffer solutions
pH 4: using 0.1M hydrochloric acid
pH 7: using 0.1M sodium hydroxide
pH 9: using 0.1M sodium hydroxide
Duration of testopen allclose all
Duration:
120 h
pH:
9
Temp.:
50
Initial conc. measured:
ca. 1 g/L
Duration:
120 h
pH:
7
Temp.:
50
Initial conc. measured:
ca. 1 g/L
Duration:
120 h
pH:
4
Temp.:
50
Initial conc. measured:
ca. 1 g/L
Number of replicates:
2
Positive controls:
yes
Negative controls:
yes

Results and discussion

Transformation products:
not measured
Dissipation DT50 of parent compoundopen allclose all
pH:
4
Temp.:
50 °C
DT50:
> 120 h
pH:
7
Temp.:
50 °C
DT50:
> 120 h
pH:
9
Temp.:
50 °C
DT50:
> 120 h

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Estimated half-life at 25°C for pH 4 / 7 / 9:
> 1 year
Executive summary:

Title: hydrolysis as a function of pH

Assessment of hydrolytic stability was carried out using Method 111 of the OECD guidelines for Testing of chemical, 13 April 2004.

The concentration of the sample solution was determined by gas chromatography (GC).

Test were done in duplicate.

There results are as follow:

Estimated half-life at 25°C for pH 4 / 7 / 9:

> 1 year