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Diss Factsheets
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EC number: 944-549-2 | 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:
- 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: 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:
- In order to verify the test concentrations, samples were collected from the test solutions at the initiation of the test (0 h), at 24 hours (old and new test solutions) and at the termination of the test (48 h). Samples of approx. 5 mL were collected in 20-mL plastic vials. Samples for chemical analysis were anonymized and only test item and concentration range was indicated on the samples. The samples were then stored at -20 ± 2.0°C. The samples were sent frozen to the analytical laboratory. The chemical analysis was performed by use of reversed-phase high-performance liquid chromatography (RP-HPLC)
- Vehicle:
- no
- Details on test solutions:
- The test item was tested at the following nominal concentrations: 0 (control); 20; 40; 75; 150 and 300 mg/L.
The reference compound K2Cr2O7 was tested at the following concentrations: 0 (control); 0.2; 0.4; 0.7; 1.0; 1.4; 2.0; and 2.8 mg/L - 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:
- The test was run as a semi-static test with renewal of all test solutions after 24 hours.
- Post exposure observation period:
- not included
- Hardness:
- 250 ± 25 mg/L expressed as CaCO3
- Test temperature:
- 19.2 ± 0.1°C
- pH:
- 7.9 ± 0.1
- Dissolved oxygen:
- 96-100% saturation
- Salinity:
- n.a.
- Conductivity:
- n.a.
- Nominal and measured concentrations:
- The test item was tested at the following nominal concentrations: 0 (control); 20; 40; 75; 150 and 300 mg/L.
Meassured concentration: Since no effects were observed only samples from the highest concentration applied were analysed.
T= 0h T= 24h (old) T= 24h (new) T=48h Geom. Mean
257.1 259.5 255.9 246.8 254.8 mg/L - Reference substance (positive control):
- yes
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 300 mg/L
- Nominal / measured:
- nominal
- 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:
- LC10
- Effect conc.:
- 300 mg/L
- Nominal / measured:
- nominal
- 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:
- EC10
- Effect conc.:
- > 254.8 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.:
- > 254.8 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- No effects were observed. Test concentrations were within within +/- 20 % of the nominal concentration throughout the test
- Results with reference substance (positive control):
- Potassium dichromate (K2Cr2O7)
EC10 (24h) = 0.8 [0.6; 0.9] mg/L
EC50 (24h) = 1.2 [1.1-1.4] mg/L - Validity criteria fulfilled:
- yes
- Conclusions:
- No mortality was observed during the study, thus an EC10 and an EC50 > 300 mg/L (nominal concentration) (> 254.8 mg/L (geom. mean concentrations)) was determined respectively.
- Executive summary:
A Daphnia sp. acute immobilization test (according to OECD Guideline no. 202) was conducted applying daphnids <24h old. The study was conducted according to GLP
The test item was tested at the following nominal concentrations: 0 (control); 20; 40; 75; 150 and 300 mg/L.
Organisms were exposed to the test item for 48h and since no mortality was observed during the study an EC10 and EC50 > 300 mg/L (nominal concentration) (> 254.8 mg/L (geom. mean concentrations)).
Reference
Description of key information
A Daphnia sp. acute immobilization test (according to OECD Guideline no. 202) was conducted applying daphnids <24h old. The study was conducted according to GLP
The test item was tested at the following nominal concentrations: 0 (control); 20; 40; 75; 150 and 300 mg/L.
Organisms were exposed to the test item for 48h and since no mortality was observed during the study an EC10 and EC50 > 300 mg/L (nominal concentration) (> 254.8 mg/L (geom. mean concentrations)).
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 254.8 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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