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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 oral administration of MI3 at dose levels of 0, 100, 300, 1000 mg/kg/d to Wistar rats during 28 days(OECD TG 407 study)produced no evidence of toxicity and no sign of effects could be attributed to the treatment. The low toxicity from repeated oral administration is most likely due to a very low degree of oral absorbtion which would apply for Insulin DesB30 as well.
Female and male rats were during 26 weeks subjected to 0.5 h of daily inhalation exposure to human insulin at concentrations of 1162 mg/m3(females) and 1979 mg/m3 (males). The exposure resulted in hypoglycaemia, however, not to an extent causing any adverse outcome.
Other groups of rats were exposed to insulin aspart* in the concentration range of 344 – 2074 mg/m3for 26 weeks. Increased mortality was observed within the first 4 weeks at the highest concnetration (3 females and 2 males). Altogether 6 females (at 1796 mg/m3a) and 3 males (at
2074 mg/m3) died at the highest dose level of insulin aspart. Lethality were noted to be due to severe hypoglycaemia. The NOAEL for insulin aspart was 804 mg/m3. The lack of effects observed using human insulin may be because the most susceptible sex (females) was exposed to a considerable lower exposure level compared to the insulin aspart study. Hence similar effects would be expected for human insulin at higher exposure levels.
*insulin aspart is an API nearly identical to human insulin as proline in position 28 of the amino acid chain in human insulin is replaced by aspartic acid in insulin aspart
See read-across template and justification attached in section 13
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEC
- 1 796 mg/m³
- Study duration:
- subchronic
- Species:
- rat
- System:
- other: Mortality
- Organ:
- not specified
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Justification for classification or non-classification
Classification: STOT RE applies if repeated or long-term exposure is associated to morbidity, death or significant functional changes in organ systems (CLP-regulation, item 3.9.2.7.3). The criteria for STOT RE category 2 classification from a 28D inhalation study is the observation of severe effects at concentration levels not higher than 600 mg/m3 for exposure 6h/day for the substance in the form of particle exposure (classification in category 1 would apply for exposure levels below 60 mg/m3). In the study with insulin aspart the severe effects/death occurred from repeated exposure during ½ hour of exposure per day at a concentration level of 1796 mg/m3. If the inhaled amount of insulin aspart during ½ hour exposure should be scaled to a 6 h exposure period (exposure of 6 h normally used in 28D inhalation study) this would then correspond to 1796 mg/m3x 0.5h/ 6 h = 150 mg / m3i.e. clearly below the classification cut-off limit of 600 mg/m3.
Based on this and the structural similarities between human insulin, insulin aspart and Insulin DesB30, Insulin DesB30 should be classified with STOT RE2; H373 (May cause damage to organs (blood sugar regulation) through prolonged or repeated exposure (inhalation)).
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