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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
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- 2006.03.23
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 8692 (Water Quality - Fresh Water Algal Growth Inhibition Test with Scenedesmus subspicatus and Selenastrum capricornutum)
- Version / remarks:
- 2012.02.15
- 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:
- One flask of the control and one flask of each test concentration without algae was used to collect samples for chemical analysis.
Duplicate samples of approx. 5 mL from the specially prepared test flasks were collected in 20-mL plastic vials at the initiation of the test and at each sampling time (24h; 48h and 72h). Samples for chemical analysis were anonymized and only test item and concentration range was indicated on the samples. The samples taken were stored at -20 ± 2.0°C and sent frozen to the analytical laboratory.
Samples relevant for the calculation of the No Observed Effect Concentration (NOEC) and the ECx concentrations were analysed.
Although duplicate samples were taken of each of the test concentrations, only one of these duplicate samples was analysed, if relevant. The other sample served as a spare sample and was discharged after sponsor’s acknowledgement of the report. - Vehicle:
- no
- Details on test solutions:
- The test item was tested at the following nominal concentrations: 0 (control); 5; 10; 20; 40; 75; 150 and 300 mg/L
The reference compound potassium dichromate (K2Cr2O7) was tested in the following concentrations: 0 (control); 0.1; 0.2; 0.4; 0.7; 1.0; 1.4 and 2.0 mg/L.
The test was run in 250-mL conical glass flasks capped with glass beakers. Each glass flask contained approx. 100 mL of test solution.
The test included three replicates of each concentration of the test item. Six control replicates was used. One flask of the control and each test concentration without algae served as blank controls during the test when measuring the fluorescence. Furthermore, one flask of the control and one flask of each test concentration without algae was used to collect samples for chemical analysis. - Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Pseudokirchneriella subcapitata (NIVA-CHL 1) is cultured at DHI. Algae from this culture was used in the study.
At the start of the test, the cell density was adjusted to approx. 6,000-10,000 cells/mL by use of a Beckman Coulter Multisizer. At the initiation of the test and at 24; 48 and 72 ± 2 hours, the in-vivo fluorescence was measured on sub-samples from each test flask by use of a Turner fluorometer.
The test flasks were stored under continuous shaking at approx. 100 rpm. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- not included
- Test temperature:
- 22.3 ± 0.1°C in a climate room
- pH:
- pH at start: 7.9; pH at termination 7.9-9.4.
- Nominal and measured concentrations:
- Nominal concentrations: 0 (control); 5; 10; 20; 40; 75; 150 and 300 mg/L
Measured concentrations (Geom. mean): 0; 2.6; 6.6; 15.3; 32.3; 64.7; 129.6 and 257.4 mg/L - Details on test conditions:
- illumination from a panel of fluorescent light with an intensity of 60-120 µmol/m2 × s
- Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (K2Cr2O7)
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 300 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 300 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 300 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 300 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 258 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- > 258 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 258 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 258 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- The geometric mean concentration was determine to 258 mg/L
- Results with reference substance (positive control):
- Potassium dichromate (K2Cr2O7)
NOEC = 0.1 mg/L
LOEC = 0.2 mg/L - Validity criteria fulfilled:
- yes
- Conclusions:
- No effects were observed during the study. Based on growth rate a NOEC = 300 mg/L and LOEC > 300 mg/L (nominal, geom. mean concentration)
Data did not allow statistical calculation of the limit of the 95% confidence interval. EC10, EC20 and EC50 (72h) are all reported as >300 mg/L (nominal concentration) (>258 mg/L geo. mean concentration) - Executive summary:
A Freshwater Alga and Cyanobacteria, Growth Inhibition Test was conducted according to Guideline no 201. The study was conducted according to GLP.
The following concentrations were applied: 0 (control); 5; 10; 20; 40; 75; 150 and 300 mg/L
No effects were observed during the study. Based on growth rate a NOEC = 300 mg/L, a LOEC > 300 mg/L and an EC10, EC20 and EC50 (72h) >300 mg/L (nominal concentration) ( ( >258 mg/L geo. mean concentration) were determined during the study.
Reference
Description of key information
A Freshwater Alga and Cyanobacteria, Growth Inhibition Test was conducted according to Guideline no 201. The study was conducted according to GLP.
The following concentrations were applied:0 (control); 5; 10; 20; 40; 75; 150 and 300 mg/L
No effects were observed during the study. Based on growth rate aNOEC =300mg/L, a LOEC > 300 mg/Land an EC10, EC20and EC50 (72h) >300mg/L (nominal concentration) (( >257.4 mg/L geo. mean concentration)were determined during the study.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 257 mg/L
- EC10 or NOEC for freshwater algae:
- 257 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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