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EC number: 201-244-2 | CAS number: 80-04-6
- 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:
- 15 January 2003 to 19 January 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Radiolabelling:
- no
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products: 0, 2.4, 72 and 120 hours
- Sampling method: Two samples were removed from the bath and an aliquot (2.5 ml) of each was diluted to volume (5 ml) with methanol
- Sampling intervals/times for pH measurements: 0, 2.4, 72 and 120 hours
- Sample storage conditions before analysis: 50°C waterbath in the dark - Buffers:
- Preparation of buffer solutions
Buffer solutions were prepared as follows:
pH 4: 0.2M aqueous potassium dihydrogen orthophosphate (550 ml) was mixed with 0.07M aqueous disodium hydrogen orthophosphate dodecahydrate (1250 ml) and purified water (3200 ml). The pH was adjusted to 4.0 ± 0.05 with orthophosphoric acid.
pH 7: 0.2M aqueous potassium dihydrogen orthophosphate (1250 ml) was mixed with 1M sodium hydroxide (150 ml) and purified water (3600 ml). The pH was adjusted to 7.0 ± 0.05 with 1M sodium hydroxide.
pH 9: 0.1M boric acid in 0.1M aqueous potassium chloride (2000 ml) was mixed with 1M sodium hydroxide (84 ml) and purified water (1920 ml). The pH was measured as 9.0 ± 0.05. - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used: Aliquots (100 µl) of a stock solution of Rikabinol HB in methanol (9 g/l) were added to separate Wheaton vials containing buffer solution (10 ml).,
- Sterilisation method: Flasks had been purged with nitrogen and pre-equilibrated at test temperature (50 ± 0.5°C).
- Measures to exclude oxygen: Flasks had been purged with nitrogen and pre-equilibrated at test temperature (50 ± 0.5°C).
TEST MEDIUM
A stock calibration solution of approximate concentration 9 g/l was prepared by weighing test substance (approximately 225 mg) into a 25 ml volumetric flask and dissolving in and diluting to volume with methanol.
Calibration solutions in the range 9 to 90 mg/l were prepared by dilutions of the stock solution with methanol:water (1:1 v/v).
OTHER TEST CONDITIONS
- Adjustment of pH: buffer solutions - Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 9 mg/L
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 9 mg/L
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- ca. 9 mg/L
- Number of replicates:
- 1
- Positive controls:
- no
- Negative controls:
- no
- Preliminary study:
- The preliminary study showed that at each of pH 4, 7 and 9 and 50 ± 0.5ºC, less than 10% hydrolysis had occurred after 120 hours (5 days), equivalent to a half-life of greater than 1 year under environmental conditions (25°C). No further testing was considered necessary.
- Test performance:
- Not required
- Transformation products:
- no
- Details on hydrolysis and appearance of transformation product(s):
- Rikabinol HB was determined to be hydrolytically stable under acidic, neutral and basic conditions.
- Key result
- pH:
- 4
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: regression coefficient of 0.9997
- Key result
- pH:
- 5
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: regression coefficient of 0.9997
- Key result
- pH:
- 9
- Temp.:
- 50 °C
- DT50:
- > 1 yr
- Type:
- (pseudo-)first order (= half-life)
- Remarks on result:
- other: regression coefficient of 0.9997
- Details on results:
- The preliminary study showed that at each of pH 4, 7 and 9 and 50 ± 0.5ºC, less than 10% hydrolysis had occurred after 120 hours (5 days), equivalent to a half-life of greater than 1 year under environmental conditions (25°C).
- Validity criteria fulfilled:
- yes
- Conclusions:
- Rikabinol HB was determined to be hydrolytically stable under acidic, neutral and basic conditions. Equivalent to a half-life of greater than 1 year under environmental conditions (25°C).
Reference
Preliminary test results for hydrolysis of Rikabinol HB
|
Ct (mg/l) |
||||||||
pH |
t0h |
t2.4h |
t72h |
t120h |
|||||
|
Measured |
Mean |
Measured |
Mean |
Measured |
Mean |
Measured |
Mean |
|
|
|
|
|
|
|
|
|
|
|
4 |
90, 88 |
89 |
85, 87 |
86 |
86, 84 |
85 |
87, 91 |
89 |
|
|
|
|
|
|
|
|
|
|
|
7 |
88, 90 |
89 |
88, 85 |
87 |
87, 88 |
87 |
88, 86 |
87 |
|
|
|
|
|
|
|
|
|
|
|
9 |
86, 86 |
86 |
87, 86 |
86 |
86, 88 |
87 |
87, 84 |
86 |
|
|
|
|
|
|
|
|
|
|
where Ctis the concentration of Rikabinol HB in solution at time th(in hours)
Description of key information
HBPA was determined to be hydrolytically stable under acidic, neutral and basic conditions.
Key value for chemical safety assessment
Additional information
A study was performed (Huntingdon Life Sciences, 2013, Study MOG0020) to determine the rate of hydrolysis of HBPA as a function of pH. The procedure was designed to be compatible the EC Method C.7 and the OECD test guidelines 111, and was conducted in compliance with GLP.
The preliminary study showed that at each of pH 4, 7 and 9 and 50 ± 0.5ºC, less than 10% hydrolysis had occurred after 5 days, equivalent to a half-life of greater than
1 year under environmental conditions (25°C). No further testing was considered necessary.
HBPA was determined to be hydrolytically stable under acidic, neutral and basic conditions.
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.
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