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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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
Explosiveness
Administrative data
Link to relevant study record(s)
- Endpoint:
- explosiveness, other
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Parameter:
- other: Differential Scanning Calorimetry
- Remarks on result:
- not thermal sensitive if heated under defined confinement
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No data was available for insulin DesB30. The explosiveness was determined based on read across to MI3 (S2). Determination of the explosive properties MI3 (source substance) was performed in accordance to EC Directive 92/69/EEC Methods A14. It is concluded that the potential for explosion is unlikely to be present based on the following three observations/results. (1) The oxygen balance was considered to be outside the region of potential concern. There are no potential auxoplose/plosophore groups present in MI3 and no thermal events was observed in the thermogram (I.e. no decomposition exotherms). Consequently, the same conclusion for the target substance (Insulin DesB30) applies, justified by the read-across hypothesis
- Executive summary:
No data was available for insulin DesB30. The explosiveness was determined based on read across to MI3 (S2).
As can be seen from the molecular structure (see attached document in section 13) 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 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 meltingpoint, boiling point, flammability, self-ignition, and explosion were identical.
Determination of the explosive properties MI3 (source substance) was performed in accordance to EC Directive 92/69/EEC Methods A14. It is concluded that the potential for explosion is unlikely to be present based on the following three observations/results. (1) The oxygen balance was considered to be outside the region of potential concern. There are no potential auxoplose/plosophore groups present in MI3 and no thermal events was observed in the thermogram (I.e. no decomposition exotherms). Consequently, the same conclusion for the target substance (Insulin DesB30) applies justified by the read-across hypothesis.
- Endpoint:
- explosiveness, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003.06.30 - 2003.07.14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.14 (Explosive properties)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL (MI3)
- Appearance: cream powder
- Source and lot/batch No.of test material: QC202426
- Expiration date of the lot/batch: June 2004
- Purity test date: 2003-06-18
- Purity: 84% w/w (stated ny Sponsor)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Frozen below - 10°C - Key result
- Parameter:
- other: Differential Scanning Calorimetry
- Remarks on result:
- not thermal sensitive if heated under defined confinement
- Conclusions:
- Determination of the explosive properties MI3 (dried) was performed in accordance to EC Directive 92/69/EEC Methods A14. MI3 is considered not to be explosive (the potential for explosion is unlikely to be present)
- Executive summary:
Determination of the explosive properties MI3 (dried) was performed in accordance to EC Directive 92/69/EEC Methods A14. It is concluded that the potential for explosion is unlikely to be present based on the following three observations/results. (1) The oxygen balance was considered to be outside the region of potential concern. There are no potential auxoplose/plosophore groups present in MI3 and no thermal events was observed in the thermogram (I.e. no decomposition exotherms).
Referenceopen allclose all
Description of key information
Data on target substance not available. Thus, read-across has been applied using 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 50 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 meltingpoint, boiling point, flammability, self-ignition, and explosion were identical.
Key value for chemical safety assessment
- Explosiveness:
- non explosive
Additional information
Justification for classification or non-classification
Determination of the explosive properties MI3 (dried) was performed in accordance to EC Directive 92/69/EEC Methods A14. It is concluded that the potential for explosion is unlikely to be present based on the following three observations/results. (1) The oxygen balance was considered to be outside the region of potential concern. There are no potential auxoplose/plosophore groups present in MI3 and no thermal events was observed in the thermogram (I.e. no decomposition exotherms). Consequently, the same conclusion for the target substance (Insulin DesB30) applies justified by the read-across hypothesis
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