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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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read Across please refer to section "justification for type of information"
- Justification for type of information:
- The aquatic toxicity of Insulin Aspart Ethyl Ester to fish is assumed to follow the same pattern as that of the source substance because of the high degree of structural similarity:
• Insulin Aspart Ethyl Ester and the source substance belong to the same chemical categories: human insulins, polypeptides and proteins
• Insulin Aspart Ethyl Ester and the source substance are composed of polypeptide containing amino acids
Please refer to Environmental Assessment Reports (Section 13) - Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 50.1 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- Insulin Aspart Ethyl Ester is predicted to have a toxicity to fish with LC50 of > 50,1 mg/L (geometric mean concentration).
The aquatic toxicity of Insulin Aspart Ethyl Ester is assumed to be similar to the source substance (S4) because of the high degree of structural similarity:
• Insulin Aspart Ethyl Ester and the source substance belong to the same chemical categories: human insulins, polypeptides and proteins
• Insulin Aspart Ethyl Ester and the source substance are composed of polypeptide containing amino acids.
No mortality to fish was observed during the study with Insulin Aspart Precursor (S4) and LC50 is therefore reported as > 50,1 mg/L (geometric mean concentration). - Executive summary:
The aquatic toxicity of Insulin Aspart Ethyl Ester is assumed to be similar to the source substance (S4) because of the high degree of structural similarity:
• Insulin Aspart Ethyl Ester and the source substance belong to the same chemical categories: human insulins, polypeptides and proteins
• Insulin Aspart Ethyl Ester and the source substance are composed of polypeptide containing amino acids.
Insulin Aspart Ethyl Ester is predicted to have a toxicity to fish with LC50 of > 50,1 mg/L (geometric mean concentration) based on the results from the study with Insulin Aspart Precursor. No mortality to fish was observed during the study with Insulin Aspart Precursor (S4) and LC50 is therefore reported as > 50,1 mg/L (geometric mean concentration).
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017.04.03 till 2017.04.07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- According to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ISO International Standard 7346-2, 1996. Water Quality – Determination of the acute lethal toxicity of substances to a freshwater fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] Part 2: Semi static method.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline No. 126: Short guidance on the threshold approach for acute fish toxicity. 2010.05.31
- GLP compliance:
- yes
- Specific details on test material used for the study:
- The test item is an intermediate. Based on information from the sponsor, the test item is:
The test item is: Insulin Aspart (IA) Precursor (NN2000 precursor)
Chemical name: Iso precipitate of IA precursor
CAS No: Not applicable
Molecular formula: C302H446N76O91S7
Purity: 90-99%
Impurities: Derivatives of IA precursor
Percentage of (significant) main impurities:
O-glycosylated derivatives, desamido derivatives and ox-idated derivatives
Typical concentration: 4.0 % w/w
Concentration Range: 1.0 – 10.0 % w/w
Form: White powder
Water solubility: Dependent of pH
Log Pow: Not possible to perform
Batch Number: K2, FHIAZG135 (undissolved substance)
Manufacturing date: 27.11.2016
Stability: In aqueous solution, stable up to 96 hours at 4°C
Origin: Novo Nordisk A/S - Analytical monitoring:
- yes
- Details on sampling:
- Duplicate samples of approx. 5 mL from the control and the test container were collected in 20-mL plastic vials at the initiation of the test and at each sampling time (0h; 48h (before and after water renewal) and 96h). The samples taken were stored at -20 ± 2.0°C and sent frozen to the analytical laboratory.
- Vehicle:
- no
- Details on test solutions:
- A stock solution of the test item was prepared by dissolving the test item in Milli-Q water at a concentration of 5 g/L. The stock solution was then dissolved in zebra fish medium to obtain a final test concentration of 125 mg/L.
The reference compound potassium dichromate (K2Cr2O7) was tested at the following concentrations: 0 (control); 50; 100; 200; 300 and 400 mg/L. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- The test was performed with zebra fish. The fish were purchased from Credo Fish, Nørresundby, Denmark. The fish arrived at DHI on 2017.02.23
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Remarks on exposure duration:
- none
- Post exposure observation period:
- not included
- Test temperature:
- Exposure group: 23.8-24.5°C
Control group: 23.1-24.1°C
The water temperature did not differ by more than ± 1.5°C between test chambers or between successive days at any time during the test - pH:
- 7.6-8.0
- Dissolved oxygen:
- 88-100%
- Salinity:
- n.a.
- Conductivity:
- n.a.
- Nominal and measured concentrations:
- Nominal: 125 mg/L
Measured concentrations:
T=0 T=48 Old T=48 New T=96
107 mg/L 11 mg/L 105 mg/L 51 mg/L - Details on test conditions:
- Limit test
Semi static. Renewal of test media every 48h. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 50.1 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- No mortality was observed. Therefore LC50 ( 96h) is reported as > 50,1 mg/L (geometric mean concentration)
- Results with reference substance (positive control):
- LC50: 200 mg/L
- Validity criteria fulfilled:
- yes
- Conclusions:
- No mortality was observed during the study with Insulin Aspart Precursor and LC50 is therefore reported as > 50,1 mg/L (geometric mean concentration)
- Executive summary:
A fish acute toxicity study (96h) was conducted with Insulin Aspart Precursor. The study was conducted according to GLP following the OECD Guideline No. 203. The study was conducted as a limit test according to the threshold approach described in the OECD Guideline No. 126.
No mortality was observed during the study. LC50 is reported as > 50.1 mg/L (geometric mean concentration).
Referenceopen allclose all
Description of key information
The ecotoxicity of Insulin Aspart Ethyl Ester is assumed to be simmilar to the source substance (S4) because of the high degree of structural similarity.
No mortality towards fish was observed during the study with Insulin Aspart Precursor (S4) and LC50 is therefore reported as > 50,1 mg/L (geometric mean concentration).
Insulin Aspart Ethyl Ester is predicted to have a toxicity towards fish of > 50,1 mg/L (geometric mean concentration).
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 50.1 mg/L
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.