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Diss Factsheets
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EC number: 478-250-9 | 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
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study report available
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 478-250-9
- EC Name:
- -
- Cas Number:
- 62965-37-1
- Molecular formula:
- C26H42N2O4
- IUPAC Name:
- (2S)-2-{[(benzyloxy)carbonyl]amino}-3,3-dimethylbutanoic acid; N-cyclohexylcyclohexanamine
Constituent 1
- Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- The following procedure was carried out at each of pH 4, 7 and 9:
Duplicate aliquots (10 ml) of a stock solution of substance in purified water (1 g/l)
were added to separate 100 ml Wheaton vials containing buffer solution (90 ml), which had
been purged with nitrogen and pre-equilibrated at test temperature (50°C). The samples, of
nominal concentration 100 mg/l, were placed in a 50°C waterbath in the dark until sampling
was required (after a short incubation period of approximately 5 minutes, and then after
2.4 and 120 hours). At each sampling time, an aliquot (1 ml) was diluted to volume (10 ml)
with mobile phase for analysis by high performance liquid chromatography (HPLC).
Sample pH and incubation temperature were monitored over the period of the test. - Buffers:
- Preparation of buffer solutions
pH 4.0 : Potassium dihydrogen orthophosphate (6.0 g) and disodium hydrogen orthophosphate dodecahydrate (12.8 g) were dissolved in purified
water (1900 ml), and the pH was adjusted to 4.0 ± 0.05 with orthophosphoric acid. The volume was then adjusted to 2000 ml with purified water.
pH 7.0 : Potassium dihydrogen orthophosphate (27.2 g) was dissolved in purified water (3800 ml), 1M sodium hydroxide (120 ml) was added and the pH was adjusted to 7.0 ± 0.05 with 1M hydrochloric acid. The volume was then adjusted to 4000 ml with purified water.
pH 9.0 : Disodium tetraborate decahydrate (66.4 g) and potassium dihydrogen orthophosphate (7.2 g) were dissolved in purified water (3800 ml), andthe pH was adjusted to 9.0 ± 0.05 with 1M hydrochloric acid. The volume was then adjusted to 4000 ml with purified water. - Details on test conditions:
- The following procedure was carried out at each of pH 4, 7 and 9:
Duplicate aliquots (10 ml) of a stock solution of VRT-126017 dcha in purified water (1 g/l)
were added to separate 100 ml Wheaton vials containing buffer solution (90 ml), which had
been purged with nitrogen and pre-equilibrated at test temperature (50°C). The samples, of
nominal concentration 100 mg/l, were placed in a 50°C waterbath in the dark until sampling
was required (after a short incubation period of approximately 5 minutes, and then after
2.4 and 120 hours). At each sampling time, an aliquot (1 ml) was diluted to volume (10 ml)
with mobile phase for analysis by high performance liquid chromatography (HPLC).
Sample pH and incubation temperature were monitored over the period of the test.
Duration of testopen allclose all
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 100 mg/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 100 mg/L
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 100 mg/L
- Number of replicates:
- no replicates necessary. Substance is stable under test conditions.
- Positive controls:
- no
- Negative controls:
- no
- Statistical methods:
- Linear regression: y = 48.25x + 3.403
(including x = 0, y = 0), r = 1.0000
Results and discussion
- Preliminary study:
- Results from the preliminary investigation showed that there was no significant change in the concentration of dcha when incubated
in pH 4, 7 and 9 buffer solutions at 50 ± 0.5 ºC. Less than 10 % hydrolysis had occurred after 120 hours (5 days) under these conditions, equivalent toa half-life of greater than 1 year under environmental conditions (25 °C). - Transformation products:
- no
- Details on hydrolysis and appearance of transformation product(s):
- no transformation produducts observed. Substance is stable under test conditions.
Dissipation DT50 of parent compoundopen allclose all
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- >= 8 760 h
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- >= 8 760 h
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- >= 8 760 h
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The test substance was determined to be hydrolytically stable under acidic, neutral and basic conditions.
The half-life time t1/2 for the hydrolytical degradation was detected > 8760 h (pH 7; 25 °C).
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