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Environmental fate & pathways

Hydrolysis

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Reference
Endpoint:
hydrolysis
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Screening test performed at 50 C
Addition pH1.2 included to simulate gastric pH
Qualifier:
according to guideline
Guideline:
OECD Guideline 111 (Hydrolysis as a Function of pH)
Version / remarks:
Additional pH1.2 added
Screening test only, 50°C
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
CAS No.: 68909-18-2
Appearance/Physical State: Brown liquid
Batch number: DD/395/113
Expiry date: 01 August 2021
Storage conditions: Room temperature in the dark
Radiolabelling:
no
Analytical monitoring:
yes
Details on sampling:
Sample solutions at pH 1.2, 4, 7 and 9 were maintained at 50.0 ± 0.5 °C for a period of 120 hours.
Duplicate sample solutions were taken initially and from the waterbath at various time points.
The pH of each solution recorded. The concentration of test item in the sample solutions was determined by high performance liquid chromatography (HPLC).
Buffers:
The test system consisted of a laboratory prepared pH 1.2 buffer solution, and commercial pH 4, 7 and 9 buffer solutions [diluted 10:90 (v/v) with high purity water].
The buffer solutions were passed through a 0.2 μm membrane filter to sterilise and subjected to ultrasonication and degassing with nitrogen to minimize dissolved oxygen.
Estimation method (if used):
These sample solutions were shielded from light whilst maintained at the test temperature.
Details on test conditions:
50.0 ± 0.5 °C for a period of 120 hours
Duration:
120 h
pH:
1.2
Temp.:
50 °C
Initial conc. measured:
ca. 100 mg/L
Duration:
120 h
pH:
4
Temp.:
50 °C
Initial conc. measured:
ca. 100 mg/L
Duration:
120 h
pH:
7
Temp.:
50 °C
Initial conc. measured:
ca. 100 mg/L
Duration:
120 h
pH:
9
Temp.:
50 °C
Initial conc. measured:
ca. 100 mg/L
Number of replicates:
Duplicates taken at 0 hours, 24 hours and 120 hours
Negative controls:
yes
Remarks:
Blank - distilled water
Preliminary study:
Substance considered stable under the initial screening at 50 C
Transformation products:
no
Remarks:
No loss of test material recorded
% Recovery:
ca. 100
pH:
1.2
Temp.:
50 °C
Duration:
120 h
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
ca. 100
pH:
4
Temp.:
50 °C
Duration:
120 h
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
ca. 100
pH:
7
Temp.:
50 °C
Duration:
120 h
Remarks on result:
hydrolytically stable based on preliminary test
% Recovery:
ca. 100
pH:
9
Temp.:
50 °C
Duration:
120 h
Remarks on result:
hydrolytically stable based on preliminary test
Remarks on result:
hydrolytically stable based on preliminary test
Validity criteria fulfilled:
yes
Conclusions:
No significant peaks were observed at the approximate retention time of the test item on analysis of any matrix blank solutions.
The estimated half-life at 25 °C of the test item is > 1 year

Description of key information

No discernable hydrolysis occoured in the screening study

No transformation products were identified

A half life of 1 years is used for the CSR

Key value for chemical safety assessment

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

Additional information