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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
Qualifier:
according to guideline
Guideline:
other: FDA-TAD no. 3.09
Deviations:
no
GLP compliance:
not specified
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ZK 00024524
Radiolabelling:
not specified
Transformation products:
no
Key result
pH:
4
Temp.:
50 °C
DT50:
> 1 yr
Type:
not specified
Remarks on result:
hydrolytically stable based on preliminary test
Remarks:
No hydrolytic degradation occurred within 5 days
Key result
pH:
7
Temp.:
50 °C
DT50:
> 1 yr
Type:
not specified
Remarks on result:
hydrolytically stable based on preliminary test
Remarks:
No hydrolytic degradation occurred within 5 days
Key result
pH:
9
Temp.:
50
DT50:
> 1 yr
Type:
not specified
Remarks on result:
hydrolytically stable based on preliminary test
Remarks:
No hydrolytic degradation occurred within 5 days
Validity criteria fulfilled:
yes
Conclusions:
No hydrolytic degradation occurred within 5 days at pH 4, 7 and 9 at 50±0.1 °C. According to the FDA-TAD no. 3.09, the test substance can therefore be considered hydrolytically stable at pH 5, 7 and 9 (t½> 1 year at 25 °C). 
Executive summary:

Hydrolysis of non-radiolabelled ZK 232105 with ZK 35760 (no concentration reported) was studiedaccording to FDA-TAD no. 3.09 at pH 5, 7 and 9. GLP conditions were not reported. No hydrolytic degradation occurred within 5 days at pH 4, 7 and 9 at 50±0.1 °C. According to the FDA-TAD no. 3.09, ZK 35760 can therefore be considered hydrolytically stable at pH 5, 7 and 9 (t½> 1 year at 25 °C).  This study is classified acceptable and satisfies the guideline requirement for hydrolysis study.

Description of key information

No hydrolytic degradation occurred within 5 days at pH 4, 7 and 9 at 50±0.1 °C. According to the FDA-TAD no. 3.09, the test substance can therefore be considered hydrolytically stable at pH 5, 7 and 9 (t½> 1 year at 25 °C). 

Key value for chemical safety assessment

Half-life for hydrolysis:
1 yr
at the temperature of:
50 °C

Additional information