Registration Dossier
Registration Dossier
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EC number: 942-225-5 | CAS number: -
Hydrolysis
Administrative data
Link to relevant study record(s)
- 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.
Reference
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
