Registration Dossier

Diss Factsheets

Environmental fate & pathways

Hydrolysis

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013-03-20 to 2013-03-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
GLP and guideline study, but no hydrolysis guideline was followed. However, detailed and well-described analytical method is available.
Qualifier:
according to guideline
Guideline:
other: Guidance for Industry Q2(R1), Validation of Analytical Procedures: Text and Methodology, November 2005, ICH
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: SANCO Guideline 3030/99 rev.4, July 11, 2000. (Annex II (part A, Section 4) and Annex III (part A, Section 5) of Directive 91/414/EEC)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Harmonized Guidelines for Single-Laboratory Validation of Methods of Analysis (IUPAC), Pure Appl. Chem., 74, 835, 2002
Deviations:
no
Principles of method if other than guideline:
In the course of the method validation the hydrolysis of the test substance was investigated.
GLP compliance:
yes (incl. QA statement)
Radiolabelling:
no
Analytical monitoring:
yes
Buffers:
No buffers were used. The test substance was dissolved in ultrapure water.
Details on test conditions:
Stock solution (1 mg/mL):
ca. 25 mg of the test item was dissolved in ultrapure water in a 25 mL volumetric flask. It was filled up to the mark with ultrapure water and thoroughly mixed.
Number of replicates:
1 replicate
Positive controls:
no
Negative controls:
no
Transformation products:
not specified
Details on hydrolysis and appearance of transformation product(s):
A transformation product, that has a retention time of ca. 3.15 minutes, was observed.
Key result
Temp.:
25 °C
Hydrolysis rate constant:
ca. 1 h-1
Details on results:
The test item rapidly decompose in contact with water. Decomposition is indicated by the difference of the chromatograms prepared in acetonitrile and in aqueous phases.

The chromatogram of the test substance, that was dissolved in ultra-pure water, shows a peak located at ca. 4.35 min (retention time), whereas the chromatogram of the test substance, that was dissolved in acetonitrile, shows a peak located at ca. 3.14 minutes (retention times).

Considering the time required for sample preparation and recording of the chromatograms the hydrolysis half-life of the test substance at 25 °C was estimated to be ca. 1 h (worst-case assumption).

Validity criteria fulfilled:
not specified
Conclusions:
The hydrolysis of the test substance in contact with water was investigated by HPLC-UV method. The test item rapidly decomposes in contact with water. Decomposition is indicated by the difference of the chromatograms prepared in acetonitrile and in aqueous phases.
Executive summary:

The hydrolysis of the test substance in contact with water was investigated by HPLC-UV method. The test item rapidly decomposes in contact with water. Decomposition is indicated by the difference of the chromatograms prepared in acetonitrile and in aqueous phases. The chromatogram of the test substance, that was dissolved in ultra-pure water, shows a peak located at ca. 4.35 min (retention time), whereas the chromatogram of the test substance, that was dissolved in acetonitrile, shows a peak located at ca. 3.14 minutes (retention times).

Description of key information

The hydrolysis of the test substance in contact with water was investigated by HPLC-UV method. The test item rapidly decomposes in contact with water. Decomposition is indicated by the difference of the chromatograms prepared in acetonitrile and in aqueous phases.

Key value for chemical safety assessment

Half-life for hydrolysis:
1 h
at the temperature of:
25 °C

Additional information

The hydrolysis of the test substance in contact with water was investigated by HPLC-UV method. The test item rapidly decomposes in contact with water. Decomposition is indicated by the difference of the chromatograms prepared in acetonitrile and in aqueous phases. The chromatogram of the test substance, that was dissolved in ultra-pure water, shows a peak located at ca. 4.35 min (retention time), whereas the chromatogram of the test substance, that was dissolved in acetonitrile, shows a peak located at ca. 3.14 minutes (retention times).

As key value for chemical safety assessment a half-life at 25 °C was estimated to be ca. 1 h (worst-case assumption).