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EC number: 814-965-8 | CAS number: 22094-84-4
- 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
- Study period:
- 24 to 27 July 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: Materia, Inc.
- Lot/batch No.of test material: RP367_ONB-D
- Expiration date of the lot/batch: 9 August 2018
- Purity test date: 9 August 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient (15°C ± 10°C), in the dark
- Stability under test conditions: Assumed stable for the duration of the test
- Solubility and stability of the test substance in the solvent/vehicle: Soluble in water <0.001g/L, expected to be stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:: None
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Both the preliminary range-finding test and the definitive test were prepared by the direct addition of measured amounts of test substance to dilution water and stirred.
In the main test, a nominal concentration (100 mg/L) was stirred for 23 hours and 5 minutes and allowed to settle for 4 hours and 30 minutes. After settling the first 100ml (approximately) of aqueous phase was removed (avoiding all settled and floating material) and discarded after filtering through Whatman 54 filter paper. The
remaining aqueous phase provided sufficient volumes for water quality measurements and testing.
FORM AS APPLIED IN THE TEST (if different from that of starting material) : Added to the test system as an aquous phase due to low water solubility (<0.001g/L).
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentration: Nominal (limit) concentration of 100 mg/L in the main test
- Sampling method: Duplicate samples were taken at the start and end of the 72 hour exposure period. Samples were taken from remaining test media after filling test vessels for 0 hours and pooled replicate flasks for 72 hours. Analysis of these samples for the verification of exposure concentrations was performed using Gas Chromatography Flame Ionisation Detection (GC/FID).
- Sample storage conditions before analysis: Ambient room temperature - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: In the main test (100 mg/L) the test concentration was stirred for 23 hours and 5 minutes and allowed to settled for 4 hours and 30 minutes. After settling, the first ca. 100ml of aqueous phase was removed (avoiding all settled and floating material) and discarded after filtering through Whatman 54 filter paper. The remaining aqueous phase provided sufficient volumes for water quality measurements and testing.
- Differential loading: All concentrations of the test substance are reported as nominal as received and are expressed as loading rates, following preparation of water accommodated fractions (WAF’s).
- Controls: Test concentrations: 0 (control) and 100 mg/L
Mean measured concentration: 0 (control) and 100 mg/L
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): No - Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: strain CCAP 278/4 (received 15 May 2018).
- Source (laboratory, culture collection): Culture Collection of Algae and Protozoa, SAMS Ltd, Scottish Marine Institute, OBAN, Argyll, PA37 1QA, Scotland, United Kingdom
- Age of inoculum (at test initiation): Not specified, from a pre-culture growing in exponential phase.
- Method of cultivation: The stocks of algal culture were maintained, and the tests performed, in nutrient growth medium as per OECD 201 requirments.t
ACCLIMATION
- Acclimation period: Not specified
- Culturing media and conditions (same as test or not): yes
- Any deformed or abnormal cells observed: No - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Remarks on exposure duration:
- 72-hour (±2h) exposure in line with OECD 201 requirements
- Post exposure observation period:
- None
- Hardness:
- Not specified
- Test temperature:
- 19.9 - 20.6°C
- pH:
- 7.36 - 8.05
- Nominal and measured concentrations:
- Test concentrations: 0 (control), 100 mg/L
Mean measured concentration: 0 (control), 1.139 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 250ml conical flask
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: Test volume: 100ml
- Initial cells density: Inoculum level adjusted to give an initial cell density of 1 x 10E04
cells/ml.
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: Yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The stocks of algal culture were maintained, and the tests performed, in nutrient growth medium (OECD 201) which was prepared by adding appropriate amounts of nutrient stocks to deionised water (sterilised by autoclaving at 120°C for 15 minutes) at a pH of 7.15 (adjusted to: 8.08.
- Intervals of water quality measurement: The temperature (to 0.1°C) and light intensity (lux) within the incubator was recorded at the beginning of the study, after 24, 48 hours and at the end of the 72 hour test period. The pH (to 0.01) and temperature (to 0.1 degreeC) were recorded for each test and control solution at the beginning of the test and on the pooled replicates at the end of the 72-hour test period.
OTHER TEST CONDITIONS
- Light intensity and quality: Illumination range within incubator throughout test: 5790 - 8050 Lux (Required: 6x10E03 - 8x10E03 Lux ± 15% of recorded mean)
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: Cell densities were measured microscopically by direct cell counts on each test and control replicate, in sextuplicate at 24 hours for the control and triplicate thereafter, and in triplicate at 24, 48 and 72 hours (±2h) for the test concentrations. The cell counts were made using a haemocytometer and microscope.
TEST CONCENTRATIONS
- Range finding study: Yes
- Test concentrations: 0 (control), 0.1, 1.0, 10, 100mg/L
- Results used to determine the conditions for the definitive study: The duration of the preliminary study was 72 ± 2 hours. There was a single replicate at each concentration. Data from the preliminary test identified the 72-hour EC50 as being >100mg/L (by growth rate). - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1.139 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 1.139 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- - Observation of abnormalities (for algal test): The algal cells were examined microscopically during the determination of the cell density, all cells within the control and all test concentrations appeared normal, no morphological abnormalities were observed.
- Colour differences: When observed visually, the control conical flasks appeared colourless after 24 and 48 hours and pale green at 72 hours. The test conical flasks appeared colourless after 24 and 48 hours and pale green and colourless at 72 hours. - Results with reference substance (positive control):
- A separate reference study (ENV 11396) was run from 16 to 19 January 2017 using potassium dichromate (K2Cr2O7) as a means of checking the test procedure and sensitivity of the test species. ISO 8692:2012 quotes the 72-hour ErC50 as 1.19mg/L (SD =0.27), the result obtained in the reference test should be in the range 0.65 and 1.73mg/L (mean value ± 2 x standard deviation). The ErC50 obtained was 1.06mg/L and all validity criteria were met.
- Validity criteria fulfilled:
- yes
- Conclusions:
EC50r >1.139 mg/l; NOEC >1.139 mg/l
Reference
Study Plan Deviations: Study plan section 9.4 Additional Study Details: Definitive test: states that the light should be at an “intensity in the range 6000 - 8000 lux at the level of the test flasks and will not vary by more than ± 15% from the mean value across all test vessels.” and that the temperature should be “21 to 24°C”.
A minimum lux value of 5790 and a maximum of 8050 lux was recorded, 210 lux below and 50 lux above the recommended range. The range was also outside the ± 15% recommended range. A minimum temperature of 20.5°C was also recorded, 0.5°C below the recommended limit.
Cell densities in the control cultures increased by the required amount (a factor of at least 16) within the 72-hour test period. Therefore, test sample concentration is considered to be the controlling factor in cell density changes in the test treatments. No morphological abnormalities were evident in any of the control vessels.
Description of key information
EC50r >1.139 mg/l; NOEC >1.139 mg/l
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 1.139 mg/L
- EC10 or NOEC for freshwater algae:
- 1.139 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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