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Diss Factsheets
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EC number: 944-548-7 | 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 produced no evidence of toxicity and no sign of effects could be attributed to the treatment. I.e. due to structural similarity to insulin aspart ethyl ester the oral NOAEL of 1000 mg/kg/d is considered relevant for this substance as well in realtion to effects not mediated via insulin receptor binding as MI3 doses not bind to the insulin receptor.
In a 26 week inhalation study female and male rats were subjected to 0.5 h of daily inhalation exposure to insulin aspart aerosols in the concentration range of 344 – 2074 mg/m3for 26 weeks. Increased female mortality was observed within the first 4 weeks at a concentration level of 1796 mg/m3. The lethal outcome was found to be due to severe hypoglycaemia. Such effects were not found at an exposure level of 805 mg/m3 that can be considered as a NOAEC. This NOAEC that is in connection with the substance insulin aspart (an active pharmaceutical ingredient) that bind to the insulin receptor may be used as NOAEC for inuslin aspart ethyl ester that has been shown to bint to the human insulin receptor as well.
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
- 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
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 inhalation 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 insulin aspart should be classified with STOT RE2; H373 (May cause damage to organs (blood sugar regulation) through prolonged or repeated exposure (inhalation)). Due to the close similarities bewteen Insulin aspart (S1) and Insulin aspart ethyl ester, the target substance should therefore also be classified as STOT RE2; H373. Only the inhalational route is considered for the classification as absorption of insulin aspart ethyl ester by dermal and oral exposure route is not considered relevant.
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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