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Diss Factsheets
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EC number: 944-550-8 | 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
Endpoint summary
Administrative data
Description of key information
The physical state: Insulin DesB30 is a solid at 20 C.
Melting point: Melting point could not determined. Thermal transition/ decomposition at 185 -205 °C (read-across data)
Boiling point: Could not be determined due to decomposition (read-across data)
Relative density: About 1.342 at 20.1oC for dryed substance (read-across data)
Particle size distribution: not relevant as only used in suspension
Vapour pressure: 4.9 x 10-6 Pa at 20oC or 25oC (read-across data)
Partition coefficient: LogPow = approximately 0.4 (estimated at pH 7 .9 for aquaous solution; read-across data).
Water solubility: very pH dependent with a solubility of about 43 g/L at pH 3.6 and 393 mg/L at pH 7.9. In the interval of pH 4.5-6.5 the substance can be considered as insoluble (read-across data).
Surface tension: surface tension of a 90% saturated solution: 58.0 mN/m (read-across data)
Flash point: negligible vapour pressure and consequently will not emit flammable vapours (Read-across data)
Auto-flammability: No self-ignition observed when heated to 400 ºC (Read-across data)
Flammability: not flammable (read-across data)
Explosiveness: not explosive (read-across data)
Oxidising properties: no chemical groups with oxidising properties in the molecule
Additional information
The molecular structure the target substance is a small protein consisting of 51 amino acids have at least 48 amino acids in common with the source substances (consisting of 50-53 amino acids) and having very identical amino acid sequences.
Based on these structural similarities very similar physicochemical properties would be expected. This is further documented by the results from physicochemical guideline testing for the read-across substances MI3 (S2) and X14DesB30 (S3), where the test results found for melting point, boiling point, flammability, self-ignition, and explosion were identical. The vapour pressure determined for S2 is extremely low but consistent to what would be expected, as a single amino acid on its own has a very low vapour pressure (below 0.4 Pa) and thus, a protein of more than 50 amino acids would have an even lower vapour pressure. Based on these data and the marginal differences in composition between the target and the source chemicals a read-across approach for physicochemical properties using data on S1 (human insulin), S2 and S3 is considered scientifically justified.
For further details, please refer to read across justification document in section 13
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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