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EC number: 264-780-6 | CAS number: 64338-16-5
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_environmental-fate-and-pathways.png)
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]-henicosan-21-one
- EC Number:
- 264-780-6
- EC Name:
- 2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]-henicosan-21-one
- Cas Number:
- 64338-16-5
- Molecular formula:
- C22H40N2O2
- IUPAC Name:
- 2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11⁸.2⁶]henicosan-21-one
- Details on test material:
- - Name of test material: Hostavin N 20 P
- Molecular formula: C22H40N2O2
- Molecular weight: 364 g/mol
- Physical state: Solid, white powder
-
Constituent 1
- Radiolabelling:
- no
Study design
- Details on sampling:
- - Sampling intervals for the parent/transformation products:
For pH 4, 7 and 9, samples were taken at test start (0 h) and at test end (120 h).
All test item containing samples were analysed immediately (max. 30 minutes until start of analyses) via UPLC-MS. - Buffers:
- - pH: 1.2, 4, 7, 9
- Type and final molarity of buffer:
Buffer solution pH 4 45 mL of 0.1 mol/L NaOH were mixed with 250 mL 0.1 mol/L KH2-Citrate and diluted to 500 mL with double distilled water.
Buffer solution pH 7 148.15 mL of 0.1 mol/L NaOH were mixed with 250 mL 0.1 mol/L KH2PO4, diluted to 500 mL with double distilled water.
Buffer solution pH 9 106.5 mL of 0.1 mol/L NaOH were mixed with 250 mL 0.1 mol/L H3BO3 in 0.1 mol/L KCL, diluted to 500 mL with double distilled water.
Buffers were prepared on 2012-01-31, purged with nitrogen for 5 minutes and the pH was checked. The buffer solutions were sterilised by filtration through 0.22 µm on 12-02-01. - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: Sterile amber HPLC vials, volume: 4 mL
- Measures taken to avoid photolytic effects: Photolytic effects were avoided by exclusion of direct light
- Measures to exclude oxygen: Buffers were purged with nitrogen for 5 min, permanent nitogen flow during incubation
- Is there any indication of the test material adsorbing to the walls of the test apparatus? No
TEST MEDIUM
- Volume used/treatment: 4 mL
- Preparation of test medium: 10 mg test item/L in respective buffer solution
- Renewal of test solution: None
Duration of testopen allclose all
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- other: 9.21 % degradation at pH 9
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- other: 9.21 % degradation at pH 9
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- other: 9.21 % degradation at pH 9
- Number of replicates:
- test item: duplicates
control: single - Positive controls:
- no
- Negative controls:
- yes
- Remarks:
- buffer solutions (pH 4, 7 and 9)
Results and discussion
- Preliminary study:
- Degradation was calculated as the percentage loss of the test item over the time. In the preliminary test, the test item was found to be stable at pH 4, 7 and 9, respectively. No further testing was deemed necessary as less than 10 % of the applied test item were transformed after 120 hours (5 days) at each of the three pH values.
- Test performance:
- Chronological Test Description:
- Method validation
- Preparation of the sterile test solutions (experimental starting)
- Thermostatisation of the test solutions
- Analysis of samples
- Evaluation of reaction rate constants and half lives for the test
item - Transformation products:
- no
Dissipation DT50 of parent compound
- Remarks on result:
- hydrolytically stable based on preliminary test
- Details on results:
- TEST CONDITIONS
- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes
Any other information on results incl. tables
Hydrolysis Results for the test item at pH 4 and 50 °C
Hydrolysis Time [hours] |
Replicate |
Concentration [mg/L] |
Mean |
Degradation [%] |
0 |
1 |
1.54 |
1.52 |
- |
2 |
1.50 |
|||
120 |
1 |
1.52 |
1.51 |
0.66 |
2 |
1.49 |
Hydrolysis Results for the test item at pH 7 and 50 °C
Hydrolysis Time [hours] |
Replicate |
Concentration [mg/L] |
Mean |
Degradation [%] |
0 |
1 |
1.47 |
1.48 |
- |
2 |
1.49 |
|||
120 |
1 |
1.56 |
1.56 |
0.00 |
2 |
1.56 |
Hydrolysis Results for the test item at pH 9 and 50 °C
Hydrolysis Time [hours] |
Replicate |
Concentration [mg/L] |
Mean |
Degradation [%] |
0 |
1 |
1.53 |
1.52 |
- |
2 |
1.51 |
|||
120 |
1 |
1.36 |
1.38 |
9.21 |
2 |
1.40 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The test item was found to be stable in the preliminary test at pH 4, 7 and 9 at 50 °C (Table 1). Reaction rate constants and half lives could not be calculated due to the fact that the test item undergoes no significant hydrolysis. With regard to the guideline a half life of > 1 year could be assumed.
- Executive summary:
Hydrolysis as a function of pH was determined according to OECD Guideline No. 111 and Council Regulation (EC) No. 440/2008, Method C.7 for the test item.
The study was conducted with test item concentrations of 1.5 mg/L in buffer solutions at pH 4, 7 and 9 at a test temperature of 50 °C (preliminary test).
Samples were taken at test start (0 hours) and test end (120 hours) and analysed via LC-MS on a reversed phase column using an external standard. Buffer solutions were analysed at test start and test end and indicated no interference with the test item. The analytical method for determination of the test item was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity.
Degradation was calculated as the percentage loss of the test item over the time. In the preliminary test, the test item was found to be stable at pH 4, 7 and 9, respectively. No further testing was deemed necessary as less than 10 % of the applied test item were transformed after 120 hours (5 days) at each of the three pH values (Table 1). Reaction rate constants and half lives could not be calculated because the test item undergoes no significant hydrolysis. With respect to the guidelines a half life of > 1 year could be assumed for ambient temperature conditions.
Degradation [%] of the test item at 50 °C after 120 Hours
Hydrolysis Time
[hours]
Degradation [%]
pH 4
pH 7
pH 9
120
0.66
0.00
9.21
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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.
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