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EC number: 688-011-2 | CAS number: 1243654-79-6
- 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
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Start of experiment: 02 December 2009 End of experiment: 08 December 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies which did not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: 13th to the 22nd of October 2008 (GLP certificate is valid for 2 years)
Test material
- Reference substance name:
- Pellicer
- IUPAC Name:
- Pellicer
- Details on test material:
- Name: Pellicer
Lot No.: 01-09-17
Chemical name: L-Lysine,N2,N6-bis[N-(1-oxododecyl)-L-α(or γ)-glutamyl]-, sodium salt (1;?)
Appearance: White powder
Storage condition: Room temperature (15-25 °C), in the dark and protected from humidity (with desiccant)
Manufacture date: 17 January 2009
Expiry Date: 17 January 2011
Safety precautions: Routine safety and hygienic procedures sufficient to ensure personnel health and safety
Constituent 1
Study design
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: The reaction solutions were analysed at the start of the test and after five days with five replicate samples each.
- Sampling intervals/times for pH measurements: The pH of each buffer solution was checked with a calibrated pH meter.
- Sample storage conditions before analysis: The tubes were thermostated at 50 °C ± 1.0 °C. : Solutions were transferred into 25 ml screw cap tubes. Five tubes were prepared from each test solution - Buffers:
- Buffer solutions: : Hydrolysis was examined at three different pH values: 4.0, 7.0 and 9.0 in the dark.
pH 4.0: 1 ml 0.2 M Sodium hydroxide and 125 ml 0.2 M Potassium hydrogen phthalate were be diluted to 500 ml with ultra-pure water
pH 7.0: 74 ml 0.2 M Sodium hydroxide and 125 ml 0.2 M Potassium dihydrogen phosphate were diluted to 500 ml with ultra-pure water
pH 9.0: 53.5 ml 0.2 M Sodium hydroxide and 125 ml 0.2 M Boric acid and Potassium chloride were diluted to 500 ml with ultra-pure water. These sterile buffer solutions were prepared using reagent grade chemicals and ultra-pure, sterile water.
The pH of each buffer solution was checked with a calibrated pH meter. - Details on test conditions:
- TEST SYSTEM
- Type, material and volume of test flasks, other equipment used:
- Sterilisation method: Nitrogen was bubbled into the water for five minutes before the preparation of the solutions in order to exclude oxygen.
- Lighting: carried out in the dark
- Measures taken to avoid photolytic effects: The hydrolysis reaction was carried out using a dark thermostat to avoid photolytic effects.
- Measures to exclude oxygen: Nitrogen was bubbled into the water for five minutes before the preparation of the solutions in order to exclude oxygen.
- If no traps were used, is the test system closed
- Dissolved oxygen: Nitrogen was bubbled into the water for five minutes before the preparation of the solutions in order to exclude oxygen.
Duration of testopen allclose all
- Duration:
- 5 d
- pH:
- 4
- Temp.:
- 50
- Initial conc. measured:
- >= 5 - <= 100 other: µg/ml
- Duration:
- 5 d
- pH:
- 7
- Temp.:
- 50
- Initial conc. measured:
- >= 5 - <= 100 other: µg/ml
- Duration:
- 5 d
- pH:
- 9
- Temp.:
- 50
- Initial conc. measured:
- >= 5 - <= 100 other: µg/ml
- Number of replicates:
- 5
- Positive controls:
- not specified
- Negative controls:
- not specified
- Statistical methods:
- None stated in the report
Results and discussion
- Preliminary study:
- The hydrolysis test was performed at 50 ± 1.0 °C, at pH 4, 7 and 9. Measured concentrations and pH values are summarised in Table 3. Please see this in the attachements section. In the course of the preliminary test Pellicer was proved to be hydrolytically stable at pH 4, 7 and 9.
- Test performance:
- The calibration series was prepared in water. It was measured at both analytical occasions. Concentrations of the calibration samples were 5, 10, 25, 50, and 100 μg / ml.
- Transformation products:
- no
Total recovery of test substance (in %)open allclose all
- % Recovery:
- < 10
- pH:
- 4
- Temp.:
- 50 °C
- % Recovery:
- < 10
- pH:
- 7
- Temp.:
- 50 °C
- % Recovery:
- < 10
- pH:
- 9
- Temp.:
- 50 °C
- Details on results:
- Pellicer is considered to be hydrolytically stable and therefore no additional testing is required.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- The validity criteris was fulfilled for this study
- Conclusions:
- The observed hydrolysis of Pellicer was less than 10 per cent after 5 days at a temperature of 50 °C at each of the three pH values.
- Executive summary:
In the course of the preliminary test Pellicer proved to be hydrolytically stable at pH 4, 7 and 9. The observed hydrolysis of Pellicer was less than 10 per cent after 5 days at a temperature of 50 °C at each of the three pH values. Therefore Pellicer is considered to be hydrolytically stable under the conditions of this test.
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