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Diss Factsheets
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EC number: 261-204-5 | CAS number: 58302-43-5
- 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 plants other than algae
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic plants other than algae
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study; GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 221 (Lemna sp. Growth Inhibition Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- The test solutions were collected from each concentration and control at test initiation and completion. At test initiation, samples of the test solutions were collected from the vessels used to prepare the test solutions (bulk). At test completion, sub-samples of test solution were pooled from each of the three (or six for the control) replicates to create one sample per concentration. Approximately 40 mL of each test concentration and the control were collected in glass containers of appropriate size and stored at ambient temperature until analysis. Samples were analysed as soon after sampling as possible. Approximately 1L of control media was also collected at this time.
- Vehicle:
- no
- Details on test solutions:
- Since the Test Item was soluble in water, a stock solution was prepared at 100 mg Test Item/L and test solutions were prepared as dilutions of this stock.
To prepare the stock solution (100 mg Test Item/L), 0.2000 g ± 0.0005 g of Test Item was weighed out and rinsed into a sterile 2L glass volumetric flask containing approximately 500 mL of sterile SIS media which was then brought up to ~1000 mL with SIS media. The solution, after being stirred for approximately 30 minutes, was then topped up to the 2L mark using sterile SIS media and mixed well by inversion.
Seven test concentrations were prepared from this stock solution and tested with a laboratory control (dilution water only). The stock and test solutions were prepared in a laminar flow hood using sterile techniques.
Each pre-sterilised 250 mL test vessel was rinsed with the appropriate test solution before the ~125 mL test volume was dispensed. Three replicate test vessels of each Test Item concentration and six replicate test vessels of the laboratory control were prepared. - Test organisms (species):
- Lemna minor
- Details on test organisms:
- Test organism species: Lemna minor
Source of test animals: Canadian Phycological Culture Centre, Waterloo, ON, Canada.
Age of inoculum at test initiation: 7 – 10 days old - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 7 d
- Test temperature:
- 24 ± 2°C
- pH:
- 6.7 - 7.9
- Salinity:
- n/a
- Nominal and measured concentrations:
- Nominal: 1.56, 3.12, 6.25, 12.5, 25, 50, and 100 mg Test Item/L
Geo. Mean Measured: 1.36, 2.77, 5.41, 10.34, 19.80, 37.92, and 63.93 mg Test Item/L - Details on test conditions:
- Test type: Static
Duration: 7 days
Test organism species: Lemna minor
Source of test animals: Canadian Phycological Culture Centre, Waterloo, ON, Canada.
Age of inoculum at test initiation: 7 – 10 days old
Test temperature: 24 ± 2 °C
Photo‐period: Continuous 24‐h light
Light intensity and quality: 85 – 135 μE/m2/s (or 6500 – 10000 lux for cool‐white fluorescent)
Control/dilution water: Synthetic growth medium; Swedish Standard (SIS)
Test vessels: 250 mL Erlenmeyer flask; sealed with foam plugs
Test volume: ~125 mL
Replicates: 3 replicates for test item concentrations and 6 replicates for the control, with a total of 9 – 12 fronds per replicate
Controls: Lab control (dilution water only)
Nominal Concentrations 1.56, 3.12, 6.25, 12.5, 25, 50, and 100 mg Test Item/L
Water quality measurements: Temperature daily in monitoring vessel; pH at beginning and end of test
Measurement Endpoints: Frond number and dry weight; EC50, LOEC, and NOEC values for yield and average specific growth rate - Reference substance (positive control):
- yes
- Remarks:
- nickel sulphate hexahydrate
- Duration:
- 7 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 63.9 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 7 d
- Dose descriptor:
- EC20
- Effect conc.:
- 22.2 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 7 d
- Dose descriptor:
- EC10
- Effect conc.:
- 7.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 7 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 63.9 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 7 d
- Dose descriptor:
- EC20
- Effect conc.:
- 20.3 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 7 d
- Dose descriptor:
- EC10
- Effect conc.:
- 8.73 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Validity criteria fulfilled:
- yes
Reference
Description of key information
There is high probability that the product is not acutely harmful to aquatic plants.
Key value for chemical safety assessment
Additional information
The toxicity of the test item was assessed in a study conducted according to OECD guideline 221 under consideration of GLP. A study according to OECD 221 was chosen because the test item is a colorant. The intensive coloration of the test solutions interfere with the growth of unicellular algae which are used in a regular OECD 201 test. For the Lemna study a stock solution at 100 mg/L was prepared. This stock was used to prepare the final test concentrations. 1.56, 3.12, 6.25, 12.5, 25, 50 and 100 mg/L were used as final test concentrations. The test was conducted as static test. After an exposure time of 7 days the EC50 for growth rate was determined to be > 63.9 mg/L based on frond number. The 7-Day EC50 for growth rate based on dry weight was > 63.9 mg/L.
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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