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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
Boiling point
Administrative data
Link to relevant study record(s)
- Endpoint:
- boiling point
- 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
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Remarks on result:
- not determinable
- Remarks:
- A drop in baseline at approximately 250°C was assumed to be the start of decomposition, which would be a characteristic of a protein. It was not possible to determine the boiling point.
- Conclusions:
- Data on Insulin DesB30 is not available. Thus, read-across has been applied using data from source substances (S2, S3).
As can be seen from the molecular structure. 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 determination of the boiling point for S2 (MI3) and S3 (X14desB30) was performed using DSC in accordance to OECD guideline 103 (1995) and EC Directive 92/69/EEC Methods A2. Boiling point was not determinede due to decomposition. Therefore, the same conclusion for the target substance (Insulin DesB30) applies, justified by the read-across hypothesis. - Executive summary:
Data on Insulin DesB30 is not available. Thus, read-across has been applied using data from source substances (S2, S3).
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 melting point, boiling point, flammability, self-ignition, and explosion were identical.
The determination of the boiling point for S2 (MI3) and S3 (X14desB30) was performed using DSC in accordance to OECD guideline 103 (1995) and EC Directive 92/69/EEC Methods A2. Boiling point was not determinede due to decomposition. Therefore, the same conclusion for the target substance, Insulin DesB30, applies, justified by the read-across hypothesis.
- Endpoint:
- boiling point
- 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:
- OECD Guideline 103 (Boiling Point)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.2 (Boiling Temperature)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- differential scanning calorimetry
- 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
- Decomposition:
- yes
- Decomp. temp.:
- ca. 250 °C
- Remarks on result:
- not determinable
- Remarks:
- due to decomposition at 250°C , which is characteristic of a protein
- Conclusions:
- Determination of the melting temperature was performed in accordance to OECD guideline 103 (1995) and EC Directive 92/69/EEC Methods A2. The thermal behavior of MI3 (dried) was assessed by Differential Scanning Calorimetry. It was not possible to determine the boiling point.
- Executive summary:
Determination of the melting temperature was performed in accordance to OECD guideline 103 (1995) and EC Directive 92/69/EEC Methods A2. The thermal behavior of MI3 (dried) was assessed by Differential Scanning Calorimetry. A drop in baseline at approximately 250°C was assumed to be the start of decomposition of MI3 (dried), which would be a characteristic of a protein.
It was not possible to determine the boiling point.
- Endpoint:
- boiling point
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003.05.12 -2003.10.24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 103 (Boiling Point)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.2 (Boiling Temperature)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- differential scanning calorimetry
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL (X14desB30, dried)
- Appearance: cream powder
- Source and lot/batch No.of test material: QX14203119
- Expiration date of the lot/batch: June 2004
- Purity test date: 2003-06-18
- Purity: 75% w/w
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL - Key result
- Decomposition:
- yes
- Decomp. temp.:
- ca. 250 °C
- Remarks on result:
- not determinable
- Remarks:
- decomposition at approximately 250 degrees celcius
- Conclusions:
- Determination of the boiling point of X14desB30 was performed using DSC in accordance to OECD guideline 103 (1995). No boiling point was observed.
- Executive summary:
Determination of the boiling point of X14desB30 was performed using DSC in accordance to OECD guideline 103 (1995) and EC Directive 92/69/EEC Methods A2. A sharp decrease in the baseline at approximately 250°C, which was assumed decomposition of the X14desB30 (dried), which is also the characteristic of a protein. No boiling point was observed.
Referenceopen allclose all
A sudden decrease in the baseline and lower stability at approximately 250°C, which was assumed to be decomposition of the MI3 (dried), also characteristic of a protein.
In both scans a sharp decrease in the baseline at approximately 250°C, which was assumed decomposition of the X14desB30 (dried), which is also the characteristic of a protein.
Description of key information
Data on target substance is not available. Thus, read-across has been applied using data from source substances (S2, S3).
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 melting point, boiling point, flammability, self-ignition, and explosion were identical.
Specifically, for S2 and S3 substances no boiling point could be determined due to decomposition.
Key value for chemical safety assessment
Additional information
The determination of the boiling point for S2 (MI3) and S3 (X14desB30) was performed using DSC in accordance to OECD guideline 103 (1995) and EC Directive 92/69/EEC Methods A2. Boiling point was not determinede due to decomposition. Therefore, the same conclusion for the target substance (Insulin DesB30) applies justified by the read-across hypothesis attached 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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