Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 944-553-4 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 September 2016 to 4 October 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Version / remarks:
- (version 2004)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Version / remarks:
- (version 2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Radiolabelling:
- no
- Analytical monitoring:
- not required
- Remarks:
- Tier 1 showed no degradation of >10% at any of the tested pHs.
- Details on sampling:
- Complete vessels were used for analysis at the beginning and after 5 days.
- Buffers:
- - pH4: 80 mL 2M CH3COOH + 40 mL 1M CH3COONa filled up to 1000 mL with demineralised water. pH adjusted to 4.00 with NaOH.
- pH7: 8.7086 g KH2PO4 in 250 mL demineralised water + 14.9 mL 2M NaOH filled up to 1000 mL with demineralised water. pH adjused to 7.00 with NaOH.
- pH9: 3.0932 g K3BO3 + 3.7292 g KCl in 500 mL demineralised water + 10.75 mL NaOH filled up to 1000 mL with demineralised water. pH adjused to 9.00 with NaOH. - Details on test conditions:
- TEST SYSTEM
- Glass Material: All glassware was sterilized before use. Amber glass 2 mL HPLC Vials with Teflon septa were used. A large head space above the liquid was avoided.
- Incubation Chamber: Memmert ICP 600 set to 50 °C
PERFORMANCE OF THE STUDY
- Preparation of test solutions: A test item solution with a concentration of 200 mg/L was prepared. 20.4 mg test item were weighed into a 100 mL flask and water was added. The mixture was sonicated, but as after 1 h sonication non-dissolved particles were still visible, 2 mL acetonitrile were added to facilitate complete dissolution. As the solution was clear after addition of acetonitrile, the flask was filled to the mark and 2 mL water were added to reach the final concentration 200 mg/L. 10 mL test item solution were mixed with 10 mL of each hydrolysis buffer solution, resulting in 100 mg/L test item in hydrolysis buffer. These mixtures were drawn into syringes, and sterile filtrated into sterile HPLC vessels (filled nearly to the top). The pH values after mixing with the test item were 4.05, 7.12 and 9.04, respectively.
- Incubation: The solutions were purged with sterilised argon to remove oxygen, closed tightly and incubated for 120 h at 50 ± 0.5 °C in an incubation chamber. - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 100 mg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 100 mg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 100 mg/L
- Number of replicates:
- Four vials were prepared for each pH, one for analysis at t = 0 h and three for t = 120 h.
- Positive controls:
- no
- Negative controls:
- yes
- Remarks:
- Blanks (demineralised water mixed with hydrolysis buffer solutions) were prepared and incubated identically.
- Preliminary study:
- No significant signs of hydrolysis were observed at all three pH values in the preliminary test.
- Transformation products:
- no
- pH:
- 4
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 7
- Remarks on result:
- hydrolytically stable based on preliminary test
- pH:
- 9
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 4
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 7
- Remarks on result:
- hydrolytically stable based on preliminary test
- Key result
- pH:
- 9
- Remarks on result:
- hydrolytically stable based on preliminary test
- Details on results:
- - No significant signs of hydrolysis were observed at all three pH values. The test item can be considered as hydrolytically stable at pH values 4.05, 7.12 and 9.04.
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- FRET 11-0571 is hydrolytically stable.
- Executive summary:
The hydrolytic stability of FRET 11 -0571 was investigated in a study according to OECD 111 and in compliance with GLP criteria (LAUS, 2016). In this study, the substance at a nominal concentration of 100 mg/L was incubated at pH4, 7 and 9 at 50 °C for 5 days. After 5 days no significant signs of hydrolysis were observed at all three pH values. The test item can be considered as hydrolytically stable at pH values 4.05, 7.12 and 9.04.
Reference
Table: test substance measured concentrations and recovery at t = 0 h and t = 120 h
|
pH 4 |
pH 7 |
pH 9 |
Test item concentration at t = 0 h (mg/L) |
93.1 |
95.0 |
95.5 |
Test item concentration at t = 120 h (mg/L) |
88.9 |
95.6 |
96.7 |
Recovery after 120 h (%) |
95.5 |
100.7 |
101.3 |
Change over 120 h (%) |
-4.5 |
+1.7 |
+1.3 |
Notes:
- The slight increase of test item concentration in hydrolysis buffers pH 7 and 9 was not caused by sample preparation errors, the most likely cause is evaporation of water during the purging step with argon.
- The slight decrease of test item concentration in hydrolysis buffer pH 4 is uncritical
Description of key information
The substance is hydrolytically stable in an OECD TG 111 test. For chemical safety assessment the half-life for hydrolysis is determined at 1 year
Key value for chemical safety assessment
- Half-life for hydrolysis:
- 1 yr
- at the temperature of:
- 25 °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.