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EC number: 445-910-2 | CAS number: 1388152-30-4
- 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
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Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 May 2005 - 15 June 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study carried out in accordance with method C7 of commission directive 92/69/EEC and in accordance with GLP. The test material was well characterised.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 445-910-2
- EC Name:
- -
- Cas Number:
- 1388152-30-4
- Molecular formula:
- Hill formula: C24 H32 N2 O7 Si CAS formula: C15 H20 O3 Si . C9 H12 N2 O4
- IUPAC Name:
- (1R,2R)-1,3-Dihydroxy-1-(4-nitrophenyl)propyl-2-ammonium (1R, 5S)-5-(dimethylphenylsilyl)-2-(hydroxymethyl)cyclopent-2-ene-1-carboxylate
Constituent 1
- Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling intervals for the parent/transformation products:
0 hrs, 2.4 hrs, 24 hrs and 120 hrs
- Sampling method:
Duplicate aliquots (A and B) of sample material were diluted by a factor of 2 using acetonitrile and the concentration of the parent compound determined by HPLC.
- Sampling intervals/times for pH measurements:
Aliquots of the sample solutions were taken from the flask at 0, 2.4, 24 and 120hrs and the pH of each solution recorded
- Sample storage conditions before analysis:
Sample solutions were prepared in stoppered glass flasks at a nominal concentration of 0.500g/L in the three buffer solutions (pH 4, 7 and 9). The solutions were shielded from light whilst maintained at the test temperature of 50 degrees celsius . - Buffers:
- - pH:
4, 7 and 9
- Composition of buffer:- Type and final molarity of buffer:
The Buffer solution of pH 4 contained Potassium hydrogen phthalate at a concentration of 0.005 mol/ L
The Buffer solution of pH 7 contained Disodium hydrogen orthophosphate (anhydrous) at a concentration of 0.003 mol/ L, Potassium dihydrogen orthophosphate at a concentration of 0.002 mol/ L and sodium chloride at a concentration of 0.002 mol/ L.
The Buffer solution of pH 9 contained Disodium tetraborate at a concentration of 0.001 mol/ L and sodium chloride at a concentration of 0.002 mol/ L.
The buffer solutions were filtered through a 0.2um membrane filter to ensure they were sterile before commencement of the test. Also the solutions were subjected to ultrasonication and degassing with nitrogen to minimise oxygen content. - Details on test conditions:
- The solutions were shielded from light whilst maintained at the test temperature of 50 degrees celsius.
Duration of testopen allclose all
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50
- Initial conc. measured:
- 0.503 g/L
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50
- Initial conc. measured:
- 0.498 g/L
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50
- Initial conc. measured:
- 0.491 g/L
- Number of replicates:
- 2
Results and discussion
- Preliminary study:
- Sample solutions at pH 4, 7 and 9 were manintained at 50.0 +/- 0.5 Degrees celsius for a period of 5 days with no degradation observed.
- Transformation products:
- no
Total recovery of test substance (in %)open allclose all
- % Recovery:
- ca. 100
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- ca. 100
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- ca. 100
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 120 h
Dissipation DT50 of parent compoundopen allclose all
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
Any other information on results incl. tables
Sample solutions at pH 4, 7 and 9 were manintained at 50.0 +/- 0.5 Degrees celsius for a period of 5 days with no degradation observed.
Results:
pH 4 at 50.0 +/- 0.5 oC | Time (hours) | |||
0 | 2.4 | 24 | 120 | |
Concentration (g/L) | 0.491 | 0.493 | 0.496 | 0.497 |
% of initial | - | 100 | 101 | 101 |
Result at pH 4: Less than 10% hydrolysis after 5 days at 50 oC, equivalent to a half-life greater than 1 year at 25oC.
pH 7 at 50.0 +/- 0.5 oC | Time (hours) | |||
0 | 2.4 | 24 | 120 | |
Concentration (g/L) | 0.498 | 0.499 | 0.503 | 0.505 |
% of initial | - | 100 | 101 | 101 |
Result at pH 7: Less than 10% hydrolysis after 5 days at 50 oC, equivalent to a half-life greater than 1 year at 25oC.
pH 9 at 50.0 +/- 0.5 oC | Time (hours) | |||
0 | 2.4 | 24 | 120 | |
Concentration (g/L) | 0.503 | 0.499 | 0.504 | 0.500 |
% of initial | - | 99.1 | 100 | 99.3 |
Result at pH 9: Less than 10% hydrolysis after 5 days at 50 oC, equivalent to a half-life greater than 1 year at 25oC.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- Study carried out in accordance with method C7 of commission directive 92/69/EEC, without deviations and in accordance with GLP.
- Conclusions:
- The estimated half-lives of the test material at pH 4, 7 and 9 are to be >1 yr at 25 degrees celsius.
- Executive summary:
The preliminary testing has shown that the estimated half-lives of the test material at pH 4, 7 and 9 are to be >1 yr at 25 degrees celsius.
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