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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 943-098-9 | 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
- Study period:
- 16 June 2016 - 08 July 2016
- 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:
- OECD Guidelines for Testing of Chemicals (2006) No 201, "Freshwater Alga and Cyanobacteria, Growth Inhibition Test" referenced as Method C.3 of Commission Regulation (EC) 761/2009.
- Deviations:
- yes
- Remarks:
- Due to the pure and poorly water soluble nature of the test item, the test media was prepared as a saturated solution
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Samples were taken from the uninoculated control and 100% v/v saturated solution test preparation at 0 and 72 hours.
- Vehicle:
- no
- Details on test solutions:
- Due to the pure and poorly water soluble nature of the test item, the test media was prepared as a saturated solution at an initial loading rate of 10 mg/L.
A nominal amount of test item (110 mg) was dispersed in 11 liters of culture medium with the aid of propeller stirring at approximately 1500 rpm for 24 hours. After 24 hours the stirring was stopped and any undissolved test item was removed by filtration through a 0.2 μm Sartopore filter (first approximate 1 liter discarded in order to pre-condition the filter) followed by centrifugation at 40000 g for 30 minutes to give a 100% v/v saturated solution.
An aliquot (1 liter) of the stock solution was inoculated with 7.3 mL of algal suspension to give the required test concentration of 100% v/v saturated solution.
The stock solution and the prepared concentration were inverted several times to ensure adequate mixing and homogeneity. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Pseudokirchneriella subcapitata strain CCAP 278/4. Liquid cultures of Pseudokirchneriella subcapitata were obtained from the Culture Collection of Algae and Protozoa (CCAP), SAMS Research Services Ltd, Scottish Marine Institute, Oban, Argyll, Scotland. Master cultures were maintained in the laboratory by the periodic replenishment of culture medium (Section 3.3). The master cultures were maintained in the laboratory under constant aeration and constant illumination at 21 ± 1 °C.
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Test temperature:
- 24 ±1 °C
- pH:
- 8.1 - 8.9
- Nominal and measured concentrations:
- Based on the results of the range-finding test a "limit test" was conducted at a concentration of 100% v/v saturated solution to confirm that at the highest attainable test concentration no effect on algal growth was observed.
Total Organic Carbon (TOC) analysis of the 100% v/v saturated solution test preparation at 0 hours showed a measured carbon concentration of 1.51 mg/L . A decline in the measured carbon concentration was observed at 72 hours to less than the limit of quantification (LOQ) of the analytical method which was considered to be 1.0 mg C/L. - Details on test conditions:
- 250 mL glass conical flasks were used. Six flasks each containing 100 mL of solution were used for the control and 100% v/v saturated solution treatment group.
The control group was maintained under identical conditions but not exposed to the test item.
Pre-culture conditions gave an algal suspension in log phase growth characterized by a cell density of 6.89 x 105 cells per mL. Inoculation of 1 liter of test medium with 7.3 mL of this algal suspension gave an initial nominal cell density of 5 x 103 cells per mL and had no significant dilution effect on the final test concentration.
The flasks were plugged with polyurethane foam bungs and incubated (INFORS Multitron Version 2 incubator) at 24 ± 1 °C under continuous illumination (intensity approximately 7000 lux) provided by warm white lighting (380 – 730 nm) and constantly shaken at approximately 150 rpm for 72 hours. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate as the reference item at concentrations of 0.25, 0.50, 1.0, 2.0 and 4.0 mg/L.
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 other: % v/v
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 other: % v/v
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Details on results:
- Total Organic Carbon (TOC) analysis of the 100% v/v saturated solution test preparation at 0 hours showed a measured carbon concentration of 1.51 mg/L was obtained. A decline in the measured carbon concentration was observed at 72 hours to less than the limit of quantification (LOQ) of the analytical method which was considered to be 1.0 mg C/L.
Exposure of Pseudokirchneriella subcapitata to the test item gave EC50 values based on the nominal test concentration of greater than 100% v/v saturated solution. The No Observed Effect Concentration was determined to be 100% v/v saturated solution.
This study showed that there were no toxic effects at saturation. - Results with reference substance (positive control):
- Results on potassium dichromate:
ErC50 (0 – 72 h) : 1.5 mg/L; 95% confidence limits 1.3 – 1.7 mg/L
EyC50 (0 – 72 h) : 0.79 mg/L; 95% confidence limits 0.70 – 0.89 mg/L
No Observed Effect Concentration (NOEC) based on growth rate: 0.50 mg/L
No Observed Effect Concentration (NOEC) based on yield: 0.50 mg/L
Lowest Observed Effect Concentration (LOEC) based on growth rate: 1.0 mg/L
Lowest Observed Effect Concentration (LOEC) based on yield: 1.0 mg/L
The results from the positive control with potassium dichromate were within the normal ranges for this reference item, showing a clear inhibition of algal growth. - Validity criteria fulfilled:
- yes
- Conclusions:
- This study showed that there were no toxic effects at saturation. EC50, considering both growth rate inhibition and yield, is greater than 100% v/v saturation. Analytical measurement of this concentration was not possible necause under the LOQ (1 mg/L ca.).
- Executive summary:
A study was performed to assess the effect of the test item on the growth of the green alga Pseudokirchneriella subcapitata. The method followed that described in the OECD Guidelines for Testing of Chemicals (2006) No 201, "Freshwater Alga and Cyanobacteria, Growth Inhibition Test" referenced as Method C.3 of Commission Regulation (EC) No 761/2009.
Due to the pure and poorly water soluble nature of the test item, the test media was prepared as a saturated solution at an initial loading rate of 10 mg/L. Following a preliminary range-finding test, Pseudokirchneriella subcapitata was exposed to a solution of the test item at a nominal concentration of 100% v/v saturated solution (six replicate flasks) for 72 hours, under constant illumination and shaking at a temperature of 24 ±1 °C. The test item solution was prepared by stirring an excess (10 mg/L) of test item in culture medium using a propeller stirrer at approximately 1500 rpm for 24 hours. After the stirring period any undissolved test item was removed by filtration (0.2 μm Sartorius Sartopore filter, first approximate 1 liter discarded in order to pre-condition the filter) followed by centrifugation at 40000 g for 30 minutes to produce a 100% v/v saturated solution of the test item. Samples of the algal populations were removed daily and cell concentrations determined for each control and treatment group, using a Coulter® Multisizer Particle Counter.
Total Organic Carbon (TOC) analysis of the 100% v/v saturated solution test preparation at 0 hours showed a measured carbon concentration of 1.51 mg/L was obtained. A decline in the measured carbon concentration was observed at 72 hours to less than the limit of quantification (LOQ) of the analytical method which was considered to be 1.0 mg C/L. Exposure of Pseudokirchneriella subcapitata to the test item gave EC50 values based on the nominal test concentration of greater than 100% v/v saturated solution. The No Observed Effect Concentration was determined to be 100% v/v saturated solution. This study showed that there were no toxic effects at saturation.
Reference
Description of key information
Exposure of Pseudokirchneriella subcapitata to the test item, in a study according to OECD TG 201, gave EC50 values based on the nominal test concentration of greater than 100% v/v saturated solution.
The No Observed Effect Concentration was determined to be 100% v/v saturated solution. This study showed that there were no toxic effects at saturation.
Key value for chemical safety assessment
Additional information
The concentration of substance in the 100% v/v saturated solution was not possible because it was under the LOQ (1 mg/L ca.).
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.