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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 921-114-5 | 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:
- 05 Dec 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Vehicle:
- yes
- Remarks:
- water
- Details on test solutions:
- A stock preparation with a test item concentration of 100 mg/L was freshly prepared.
Out of the stock solution 5 concentration levels were tested in a geometrical series with a dilution factor of 1.25, 2.5, 5.0, 10.0 and 20.0 mg/L (nominal), corresponding to the geometric mean measured concentrations 1.07, 2.15, 4.88, 10.1 and 19.9 mg/L.The concentration levels are based on the results of a preliminary range finding test. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Test organism: Pseudokirchneriella subcapitata HINDAK, SAG 61.81
Origin:
Sammlung von Algenkulturen (SAG), Pflanzenphysiologisches Institut der Universität Göttingen, Göttingen, Germany - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 22.0-23.5 °C
- pH:
- 7.80 - 9.32
- Nominal and measured concentrations:
- nominal: 1.25, 2.50, 5.00, 10.00, 20.00 mg/L
geometric mean measured: 1.07, 2.15, 4.88, 10.1, 19.9 mg/L - Details on test conditions:
- The study was performed as a static test in open vessels under culture conditions. The flasks contained 100 mL either reconstituted water or test medium (test item group).
The duration of exposure was 72 hours. The algal biomass in each flask was determined daily during the exposure period via Chlorophyll a-fluorescence. Microscopic evaluation of the cells at the start and at the end of the incubation period was carried out. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 9.32 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.:
- 3.06 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): Microscopic evaluation of the cells at the start revealed no morphological abnormalities. At the end rounded cells (no typical sickle shape) were found at concentration levels 19.9 - 4.88 mg/L. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- EC50: 72-h EC50 = 0.559 mg/L based on growth rate - Validity criteria fulfilled:
- yes
- Conclusions:
- The 72 h EC50 for growth rate and yield were 9.32 and 3.34 mg/L. The EC10 value for inhibition of growth rate after 72 h was 3.06 mg/L.
- Executive summary:
The toxicity of the test item to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined according to the principles of OECD 201 and Council Regulation (EC) No. 266/2016 C.3. The aim of the study was the determination of NOEC, LOEC, EC10, EC20- and EC50-values of growth rate and yield over a period of 72 hours.
The study was conducted under static conditions with an initial cell density of 6839 cells/ml. A stock solution with a nominal test item concentration of 100 mg/L was freshly prepared with dilution water one day prior to the start of exposure. The stock solution was stirred for 24 hours at room temperature, 1100 rpm. Undissolved particles were removed by membrane filtration (membrane filter 0.45 µm, RC, MACHEREY-NAGEL). The filter was saturated in order to avoid adsorption during the filtration. The first 25 mL of the filtrate were discarded. The filtration was interrupted for 10 minutes to allow adsorption and saturation of the filter material with dissolved test item.Thereafter, the filtration was continued. The next 25 ml were discarded. The following filtrate was used in the test. During filtration, the filter was always be kept covered.The solution was checked via laser beam (Tyndall effect) for undissolved test item, which was negative.
Out of the stock solution five concentration levels were tested in a geometrical series with a factor of 2: 1.25 - 2.50 - 5.00 - 10.0 - 20.0 mg/L, corresponding to the geometric mean measured test item concentrations 1.07 - 2.15 - 4.88 - 10.1 - 19.9 mg/L. Three replicates were tested for each test item concentration and six replicates for the control. The environmental conditions were within the acceptable limits.
The concentrations of the test item were determined at the start of the exposure (0 hours) and at the end of the exposure (72 hours) of all tested solutions and the control via HPLC-DAD.
The measured concentrations of the test item were between 101% and 103% at the start of the exposure (0 hours) and between 72 and 102% at the end of the exposure (72 hours). Since the measured test item concentrations were not within the range of ± 20% of the nominal concentrations, the geometric mean measured concentrations were calculated.
All effect values given are based on the geometric mean measured test item concentrations of the test item.
The EC50-value with 95% confidence interval for inhibition of growth rate (ErC50) after 72 hours was 9.32 (8.97 - 9.70) mg/L. The EC10-value with 95% confidence interval for inhibition of growth rate (ErC10) after 72 hours was 3.06 (2.80 – 3.33) mg/L.
Reference
Table 1:NOEC, LOEC, ECx-values and 95%Confidence lntervals of the test item
(0-72 hours)
based on geometrie mean measured test item eoneentrations [mg/L]
|
Growth Rate Inhibition Geometrie mean measured test item eoncentration [mg/L] |
NOEC |
1.07 |
LOEC |
2.15 |
ErC10 |
3.06 (2.80 - 3.33) |
ErC20 |
4.60 (4.34 -4.87) |
ErC50 |
9.32 (8.97 - 9.70) |
|
Yield Inhibition Geometrie mean measured test item eoncentration rma/Ll |
NOEC |
1.07 |
LOEC |
2.15 |
EyC10 |
1.30(<1.07 - 1.60) |
EyC20 |
1.84 (1.57 - 2.16) |
EyC50 |
3.34 (2.98 - 3.72) |
Description of key information
OECD 201: 72 -h ErC50 = 9.32 mg/L; 72 -h ErC10 = 3.06 mg/L
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 9.32 mg/L
- EC10 or NOEC for freshwater algae:
- 3.06 mg/L
Additional information
The toxicity of the test item to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined according to the principles of OECD 201 and Council Regulation (EC) No. 266/2016 C.3. The aim of the study was the determination of NOEC, LOEC, EC10, EC20- and EC50-values of growth rate and yield over a period of 72 hours.
The study was conducted under static conditions with an initial cell density of 6839 cells/ml. A stock solution with a nominal test item concentration of 100 mg/L was freshly prepared with dilution water one day prior to the start of exposure. The stock solution was stirred for 24 hours at room temperature, 1100 rpm. Undissolved particles were removed by membrane filtration (membrane filter 0.45 µm, RC, MACHEREY-NAGEL). The filter was saturated in order to avoid adsorption during the filtration. The first 25 mL of the filtrate were discarded. The filtration was interrupted for 10 minutes to allow adsorption and saturation of the filter material with dissolved test item.Thereafter, the filtration was continued. The next 25 ml were discarded. The following filtrate was used in the test. During filtration, the filter was always be kept covered.The solution was checked via laser beam (Tyndall effect) for undissolved test item, which was negative.
Out of the stock solution five concentration levels were tested in a geometrical series with a factor of 2: 1.25 - 2.50 - 5.00 - 10.0 - 20.0 mg/L, corresponding to the geometric mean measured test item concentrations 1.07 - 2.15 - 4.88 - 10.1 - 19.9 mg/L. Three replicates were tested for each test item concentration and six replicates for the control. The environmental conditions were within the acceptable limits.
The concentrations of the test item were determined at the start of the exposure (0 hours) and at the end of the exposure (72 hours) of all tested solutions and the control via HPLC-DAD.
The measured concentrations of the test item were between 101% and 103% at the start of the exposure (0 hours) and between 72 and 102% at the end of the exposure (72 hours). Since the measured test item concentrations were not within the range of ± 20% of the nominal concentrations, the geometric mean measured concentrations were calculated.
All effect values given are based on the geometric mean measured test item concentrations of the test item.
The EC50-value with 95% confidence interval for inhibition of growth rate (ErC50) after 72 hours was 9.32 (8.97 - 9.70) mg/L. The EC10-value with 95% confidence interval for inhibition of growth rate (ErC10) after 72 hours was 3.06 (2.80 – 3.33) 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.