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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 225-060-7 | CAS number: 4635-87-4
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 JUNE 2007 to 16 AUGUST 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study follows international guidelines and comply with GLP. The study design is adapted to the test substance yet no certificate of analysis was provided therefore doubts remain whether the test substance is the reference substance of the current dossier. Thus the results are deemed reliable with this last restriction.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: 0h, 48h, 120h
- Sampling method: in duplicate
- Sampling methods for the volatile compounds, if any: No headspace was left in the vessel to stop volatilisation of the test material
- Sampling intervals/times for pH measurements: 0h, 48h, 120h
- Sampling intervals/times for sterility check: no data
- Sample storage conditions before analysis: shielded from light
- Other observation, if any (e.g.: precipitation, color change etc.): no data - Buffers:
- pH=4 - Potassium hydrogen phtalate at 0.005M
pH=7 - Disodium hydrogen orthophosphate (anhydrous) at 0.003M - Potassium dihydrogen orthophosphate (anhydrous) at 0.002M - sodium chloride at 0.002M
pH=9 - Disodium tetraborate 0.001M - Sodium chloride 0.002M
All buffers were filtered at 0.2µm - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: stoppered glass flasks.
- Sterilisation method: 0.2 µm filtration
- Lighting: prevent for samples
- Measures taken to avoid photolytic effects: no data
- Measures to exclude oxygen: solutions were subjected to ultrasonication and degassing with nitrogen to minimize dissolved oxygen content.
- Details on test procedure for unstable compounds: not applicable
- Details of traps for volatile, if any no data
- If no traps were used, is the test system closed/open: closed system with no headspace left in vessels
- Is there any indication of the test material adsorbing to the walls of the test apparatus? no
TEST MEDIUM no details
OTHER TEST CONDITIONS no details - Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50
- Initial conc. measured:
- 518 mg/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50
- Initial conc. measured:
- 508 mg/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50
- Initial conc. measured:
- 485 mg/L
- Number of replicates:
- duplicate at each time interval
- Positive controls:
- not specified
- Negative controls:
- not specified
- Statistical methods:
- no data
- Preliminary study:
- A preliminary study at 50°C was performed. Since hydrolysis half-life was estimated to be over one year at pH = 4, pH = 7 and pH = 9, the study was terminated.
- Transformation products:
- no
- Details on hydrolysis and appearance of transformation product(s):
- no further details
- % Recovery:
- > 95.4 - < 95.9
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- 103
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- 103
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- pH:
- 7
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- pH:
- 9
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Type:
- not specified
- Validity criteria fulfilled:
- yes
- Conclusions:
- The half-life of the test substance at 25°C is estimated to be over 1 year.
- Executive summary:
The hydrolysis as a function of pH was determined for the test substance following a GLP study according to OECD 111 guidelines. Solutions of 0.5 g/L of test substance in buffers at pH = 4, 7, and 9 were maintained at 50°C for 5 days and sampled at 0h, 48h, and 120h by gas chromatography.
At all tested pH, less than 10% of hydrolysis were measured, thus half-life of the test substance at 25°C was estimated to be over one year.
Reference
Description of key information
The half life of the substance is over 1 year at pH 4, 7 and 9.
Key value for chemical safety assessment
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.
