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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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- (Human Insulin Methyl Ester S5)
- 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 DesB30 to fish is assumed to follow the same pattern as that of the source substance because of the high degree of structural similarity:
• Insulin DesB30 and the source substance belong to the same chemical categories: human insulins, polypeptides and proteins
• Insulin DesB30 and the source substancs 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:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 30.1 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 30.1 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- The aquatic toxicity of Insulin DesB30 is assumed to be similar to the source substance (S5) because of the high degree of structural similarity.
• Insulin DesB30 and the source substance belong to the same chemical categories: human insulins, polypeptides and proteins
• Insulin DesB30 and the source substancs are composed of polypeptide containing amino acids
No effects to invertebrates were observed during the study with Insulin Human Methyl Ester (S5) and an EC10 and EC50 (48h) of > 30.1 mg/L (geom. mean) were determined. - Executive summary:
The aquatic toxicity of Insulin DesB30 is assumed to be similar to the source substance (S5) because of the high degree of structural similarity.
• Insulin DesB30 and the source substance belong to the same chemical categories: human insulins, polypeptides and proteins
• Insulin DesB30 and the source substancs are composed of polypeptide containing amino acids
No effects to invertebrates were observed during the study with Insulin Human Methyl Ester (S5) and an EC10 and EC50 (48h) of > 30.1 mg/L (geom. mean) were determined.
Insulin DesB30 is predicted to have a toxicity to invertebrates with LC10 and LC50 of > 30.1 mg/L based on the results from the study with Insulin Human Methyl Ester.
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- According to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004.04.13
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
- Version / remarks:
- 2012.12.18
- 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: Hi-OMe (Human Insulin Methylester)
Chemical name: Zinc crystals of HI-OMe
CAS No: Not applicable
Molecular formula: C258H385N65O77S6
Purity: 95-98%
Impurities: Derivatives of HI-OMe, desB30-Insulin, Insulin Human
Percentage of (significant) main impurities:
Typical Concentration: <3.0 % w/w
Concentration Range: 2.0 – 5.0 % w/w
Form: White powder
Water solubility: Dependent of pH
Log Pow: Not possible to perform
Batch Number: EM0Z31503
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 5 mL ((0hr, 24hr, 48hr) were collected in 20 mL plastic vials and stored at -20.0 °C
- Vehicle:
- no
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Juvenile organisms < 24 h old at the beginning of the test
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- renewal of test solution after 24 hours
- Post exposure observation period:
- not included
- Hardness:
- 272 mg CaCO3/L
- Test temperature:
- 19.3 ± 0.1°C
- pH:
- 8.1
- Salinity:
- n.a.
- Conductivity:
- n.a.
- Nominal and measured concentrations:
- Nominal: 0 (control); 20; 40; 75; 150; 300 mg/L
Only the control and the nominal concentrations 20mg/L; 75 mg/L and 300 mg/L were analysed
Meassured (geom. mean concentration): 0.5; 10.5; 19.4; 30.1 mg/L - Details on test conditions:
- Test substance: nominal concentrations: 0 (control); 20; 40; 75; 150; 300 mg/L
Reference substance: K2Cr2O7: 0.2; 0,4; 0.7; 1.0; 1.4; 1.7 and 2.0 mg/L - Reference substance (positive control):
- yes
- Remarks:
- K2Cr2O7
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LC10
- Effect conc.:
- > 30.1 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other:
- Remarks:
- no effects were observed during the study
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 30.1 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other:
- Remarks:
- no effects were observed during the study
- Details on results:
- As no effect was observed the EC values are reported as greater than the highest tested concentration (> 300 mg/L, nominal concentration)
- Results with reference substance (positive control):
- Potassium dichromate (K2Cr2O7)
EC50 (24h) = 1.2 [1.1-1.4] mg/L - Validity criteria fulfilled:
- yes
- Conclusions:
- No mortality was observed during the study and an EC10 (48h) and EC50 (48h) > 30.1 mg/L (geom. mean) were determined.
- Executive summary:
A Daphnia sp. acute immobilisation test (according to OECD Guideline no. 202) and following was conducted applying daphnids <24h old. The study was conducted according to GLP.
Concentrations were not within 20% of the nominal concentration throughout the study. And endpoints are thus reported as geometric mean concentrations (geom. mean conc.)
Organisms were exposed to the test item for 48h and since no effects were observed during the study an EC10 and EC50 (48h) > 30.1 mg/L (geom. mean) were determined.
Referenceopen allclose all
Description of key information
The ecotoxicity of Insulin DesB30 is assumed to be simmilar to the source substance (S5) because of the high degree of structural similarity.
No mortality towards invertebrates was observed during the study with Insulin Human Methyl Ester (S5) and an EC10 and an EC50 value are therefore reported as > 30.1 mg/L (geometric mean concentration).
Insulin DesB30 is predicted to have a toxicity towards invertebrates of > 30.1 mg/L (geometric mean concentration).
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 30.1 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.
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