Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | 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
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 26, 2007-November 28, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study has been performed according to OECD and EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- ISO 8692 (Water Quality - Fresh Water Algal Growth Inhibition Test with Scenedesmus subspicatus and Selenastrum capricornutum)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Physical state: Blue solid lumps
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: control and all concentrations
- Sampling method: 40 ml at t=0 h and t=48 h
- Sample storage conditions before analysis: Samples were stored in a refrigerator until analysis.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Preparation of test solutions started with loading rates of 10 and 100 mg/l. The aqueous mixtures were treated with ultrasonic waves for 15 minutes, followed by a 24-hour magnetic stirring period and a 3½ hour stabilisation period. The resulting mixture at 100 mg/l was clear and colourless but contained test substance particles, precipitate and a floating layer. The mixture at 10 mg/l was clear and colourless with a precipitate and a floating layer. Therefore, the mixtures were passed over glass wool, after which they were clear and colourless (very slightly blue at 100 mg/l).
After preparation, volumes of 50 ml were added to each replicate of the respective test concentration. Subsequently, 1 ml of an algal suspension was added to each replicate providing a cell density of 10^4 cells/ml.
Test organisms
- Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: NIVA CHL 1
- Source (laboratory, culture collection): In-house laboratory culture
- Age of inoculum (at test initiation): not indicated
- Method of cultivation:Algae stock cultures were started by inoculating growth medium with algal cells from a pure culture on agar. The suspensions were continuously aerated and exposed to light in a climate room at a temperature of 21-24°C.
ACCLIMATION
- Acclimation period: 3 days
- Culturing media and conditions (same as test or not):Stock culture medium is M1 (according to the NPR 6505, formulated using Milli-Ro water); Pre-culture medium and test medium is M2, according to the OECD 201 Guideline, formulated using Milli-Q water (tap water purified by reverse osmosis (milli-RO) and subsequently passed over activated carbon and ion-exchange cartridges: Milli-Q water; Millipore Corp., Bedford, Mass., USA) preventing precipitation.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- No post exposure observations.
Test conditions
- Hardness:
- 0.24 mmol/L (24 mg CaCO3/L)
- Test temperature:
- The temperature of the test medium was 20.2°C at the start of the test. During the exposure period the temperature measured in the incubator was maintained between 22.6 and 23.7°C. Temperature in the incubator remained within the limits prescribed by the protocol (21-24°C, constant within 2°C).
- pH:
- 8.0 - 8.1
- Nominal and measured concentrations:
- Loading rate 0 mg/L t=0h: TOC = 0.8617 mg/L
Loading rate 0 mg/L t=48h: TOC = 0.5699 mg/L
Loading rate 100 mg/L t=0h: TOC = 0.8618 mg/L
Loading rate 100 mg/L t=48h: TOC = 0.4199 mg/L
The TOC contents in treated samples were comparable to those in control samples, indicating that the actual test substance concentration was very low. This is not unexpected considering the presence of precipitate and a floating layer in the solution, which were removed by passing the solution over glass wool. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 ml, all-glass, containing 50 ml of test solution
- Aeration:
- Initial cells density: An initial cell density of 1 x 10^4 cells/ml.
- Control end cells density: 56x 10^4 cells/ml.
- No. of vessels per concentration (replicates):
6 replicates of the control and the highest test concentration
3 replicates of the lower concentration
3 replicates of the highest test concentration and the control without algae
1 replicate of the lower test concentration without algae
2 replicates of the control without algae
GROWTH MEDIUM
- Standard medium used: yes
OTHER TEST CONDITIONS
- Photoperiod: Continuously using TLD-lamps of the type ‘Cool-white’ of 30 Watt, with a light intensity within the range of 86 to 92 µE.m-2.s-1.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
at 0. 24 and 48 h
At the beginning of the test, cells were counted using a microscope and a counting chamber. Thereafter cell densities were determined by spectrophotometric measurement of samples at 720 nm using a Varian Cary 50 single beam spectrophotometer with immersion probe (pathlength =20 mm).
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10 (0, 10 and 100 mg/L)
- Range finding study: the sudy is combined limit/range finding study - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrations
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- loading rate
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): no abnormalities observed
- Results with reference substance (positive control):
- - Results with reference substance valid? yes
- EC50: The EC50 for growth rate reduction (ERC50: 0-72h) was 2.1 mg/l with a 95 % confidence interval ranging from 1.5 to 3.0 mg/l. The historical ranges for growth rate reduction lie between 0.82 and 2.3 mg/l. Hence, the ERC50: 0-72h for the present batch corresponds with this range.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- No reduction of growth rate or inhibition of yield was recorded at any of the concentrations of the test substance.
The NOEC for growth rate reduction and yield inhibition was 100 mg/l based on loading rates.
Due to the very low solubility of the test substance in water, concentration levels that might be toxic for algae could not be reached. Hence the 48h-EC50 for both growth rate reduction and yield inhibition was above a loading rate of 100 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.