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Diss Factsheets
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EC number: 944-549-2 | 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
Flash point
Administrative data
Link to relevant study record(s)
- Endpoint:
- flash point of flammable liquids
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- the study does not need to be conducted because decomposition occurred during the melting point study
- Justification for type of information:
- The molecular structure of the the target substance is a small protein consisting of 59 amino acids have at least 49 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 physical chemical properties would be expected. This is further documented by the results from physical chemical guideline testing for S2 and 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 much 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 physical –chemical properties using data on S1, S2 and S3 is considered scientifically justified. There is no reason to believe that whether the two amino acids chains in S1 and S3 are linked together as in T and S2, this would have any significant influence on the physical-chemical properties of the substances.
- Key result
- Remarks on result:
- not determinable, other reason:
- Remarks:
- The flash point of MI3 was not tested experimentally. MI3 is a proteinaceous material, which is solid at room temperature. It has negligible vapour pressure and consequently will not emit flammable vapours. This is further confirmed by the fact that no melting or boiling points could be determined.
- Conclusions:
- No melting or boiling points could be determined based on read across to MI3 (S2).
- Executive summary:
The flash point of Insulin aspart precurser (T) was determined by read across to MI3. MI3 is a proteinaceous material, which is solid at room temperature. It has negligible vapour pressure and consequently will not emit flammable vapours. This is further confirmed by the fact that no melting or boiling points could be determined.
- Endpoint:
- flash point of flammable liquids
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- the study does not need to be conducted because decomposition occurred during the melting point study
Referenceopen allclose all
Description of key information
Data on target substance not available. Data is waived based on data from source substances (S2).
As can be seen from the molecular structure (see attached document in section 13) the target substance is a small protein consisting of 59 amino acids have at least 49 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 physical chemical properties would be expected. This is further documented by the results from physical chemical guideline testing for S2 and S3 where the test results found for melting point, boiling point, flammability, self-ignition, and explosion were identical.
Key value for chemical safety assessment
Additional information
The flash point of MI3 was not tested experimentally because of decomposition during determination of the melting point. MI3 (S2) and Insulin Aspart (S1) are proteinaceous materials, which are solid at room temperature. They have negligible vapour pressure and consequently will not emit flammable vapours. This is further confirmed by the fact that no melting or boiling points could be determined.
Therefore, the same conclusion for the target substance (Insulin Aspart Precursor) applies justified by the read-across hypothesis
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