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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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
- Objective of study:
- other: receptor binding
- GLP compliance:
- no
Test material
- Reference substance name:
- Insulin DesB30
- EC Number:
- 944-550-8
- Molecular formula:
- C253H376N64O75S6
- IUPAC Name:
- Insulin DesB30
- Test material form:
- solid: particulate/powder
Constituent 1
Results and discussion
- Preliminary studies:
- From insulin receptor binding assays (Novo Nordisk 2015) the following relative binding was observed for insulin APIs and the various insulin intermediates:
Human insulin (API, two chains): 100 %
Human insulin methyl ester (two chains): 108 %
DesB 30 human insulin (two chains) : 133 %
X14DesB30 (S3, two chains): not examined
Insulin aspart (API, S1, two chains): 100% %
Insulin aspart ethyl ester (two chains): 103%
Insulin aspart precursor (T, one chain) : 0.03 %
MI3 (S2, one chain): 0.22%
These data indicate that receptor binding affinity is lost when the two amino acids chains are linked together in one chain,
most probably due to a great change in the steric form of the molecule.
Any other information on results incl. tables
From insulin receptor binding assays (Novo Nordisk 2015) the following relative binding was observed for insulin APIs and the various insulin intermediates:
Human insulin (API, two chains): 100 %
Human insulin methyl ester (two chains): 108 %
DesB 30 human insulin (two chains) : 133 %
X14DesB30 (S3, two chains): not examined
Insulin aspart (API, S1, two chains): 100 %
Insulin aspart ethyl ester (two chains): 103%
Insulin aspart precursor (T, one chain) : 0.03 %
MI3 (S2, one chain): 0.22%
These data indicate that receptor binding affinity is lost when the two amino acids chains are linked together in one chain,
most probably due to a great change in the steric form of the molecule.
Applicant's summary and conclusion
- Conclusions:
- Human insulin receptor affinity of insulin DesB30 relative to the API, human insulin, was found to be 133% [116 to 153]. Results are given as weighted means of three independent experiments with the corresponding 95% confidence intervals.
- Executive summary:
Human insulin receptor affinity of insulin DesB30 relative to the API, human insulin, was found to be 133% [116 to 153]. Results are given as weighted means of three independent experiments with the corresponding 95% confidence intervals. Thus, insulin DesB30 is expected to have identical pharmacological/toxicological properties as humna insulin with respect to effects mediated via insulin receptor binding.
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