Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 813-811-7 | CAS number: 253265-97-3
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 28 February - 13 March 2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Feasibility of the investigation of hydrolysis in function of the pH
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- yes
- Remarks:
- Due to the instability of the analytical system when injecting QC samples containing hydrolysis-testing media, validation was not possible
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- yes
- Remarks:
- Due to the instability of the analytical system when injecting QC samples containing hydrolysis-testing media, validation was not possible
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-[([[(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl]oxy]carbonyl)oxy]pyrrolidine-2,5-dione
- EC Number:
- 813-811-7
- Cas Number:
- 253265-97-3
- Molecular formula:
- C11H13NO7
- IUPAC Name:
- 1-[([[(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl]oxy]carbonyl)oxy]pyrrolidine-2,5-dione
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical state: powder
- Appearance: white powder
Constituent 1
- Specific details on test material used for the study:
- - Batch n°: I18IB2522
- Analytical purity: 100.1%
- Expiration date: 17 March 2020 (retest date)
- Storage condition: In refrigerator (2-8°C) - Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Remarks:
- Due to the instability of the analytical system when injecting QC samples containing hydrolysis-testing media, validation was not possible
Results and discussion
Any other information on results incl. tables
The gathered analytical data have shown that it was not possible to validate a method for the analysis of the test item in the media of hydrolysis testing. The stability of the measuring system declined when injecting QC samples containing hydrolysis-testing media. Probably buffer salts influenced the GC system and the column which caused fluctuations in signal intensity.
Applicant's summary and conclusion
- Conclusions:
- It was not possible to validate a method that would allow the analysis of the test item in the media of hydrolysis testing
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.
