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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 269-044-8 | CAS number: 68186-64-1
- 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:
- from 2019-05-13 to 2019-07-18
- 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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Remarks:
- LC/MS/MS
- Details on sampling:
- For determination of the test item concentration six replicate samples (3 mL per replicate) from the test concentration and six replicate samples (3 mL per replicate) from the control group were taken at the start and at the end of the test.
- Vehicle:
- no
- Details on test solutions:
- The test solution was prepared by mechanical dispersion without using any solubilizing agent. An amount of 0.0806 g test item was dissolved in 806 mL dilution water (OECD Medium) in order to obtain the concentration of 100 mg/L. Thereafter, this solution was placed into an ultrasonic bath for approximately 10 minutes.
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Green algae
- Strain: 61.81 SAG (identical strains: CCAP 278/4; UTEX 1648; ATCC 22662)
- Source: SAG: Collection of Algal Cultures, Inst. Plant Physiology, University of Göttingen, Untere Karspüle 2, D-37073 Göttingen, Germany
- Method of cultivation: on agar
ACCLIMATION
- Acclimation period: no - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Test temperature:
- 21.4 - 23.3 °C
- pH:
- 7.33 - 8.87
- Nominal and measured concentrations:
- Nominal concentration: 100 mg/L
Measured concentration: within ± 20 % of the nominal concentration - Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer flask
- Material, size, fill volume: glass, 250 mL, fill volume 100 mL
- Aeration: none
- Initial cells density: 1E4 cells/mL
- Control end cells density: 65.8E4 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: OECD Medium, prepared according to OECD 201
OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: continuously illuminated with fluorescent lamps
- Light intensity and quality: 7024 lux
EFFECT PARAMETERS MEASURED
- Determination of cell concentrations: microscope with counting chamber at 24, 48 and 72 hours
- Morphological Changes of Algal Cells: after 24, 48 and 72 hours
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: After 72-h exposure only 1.4 % inhibition was observed in the test item group. Therefore, a limit test was performed as the main test. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- and yield
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- and yield
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- and yield
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- and yield
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- and yield
- Results with reference substance (positive control):
- For the evaluation of the reliability of the applied test system and the experimental conditions Potassium dichromate is tested at least twice a year. The date of the latest study with the reference item Potassium dichromate was: 11 – 14 March 2019.
The 72-h ErC50: 0.83 mg/L, (95 % confidence limits: could not be calculated)
The 72-h EyC50: 0.57 mg/L, (95 % confidence limits: 0.45 – 0.72 mg/L) - Validity criteria fulfilled:
- yes
- Conclusions:
- The 72-h NOEC based on growth rate and yield was determined to be 100 mg/L, while the 72-h LOEC based on growth rate and yield was determined to be > 100 mg/L. The 72-h EC10, EC20 and EC50 values were determined to be > 100 mg/L.
- Executive summary:
The effect of the test item on the growth of a unicellular green algal species Raphidocelis subcapitata was determined according to OECD 201 and Regulation (EC) No. 226/2016 Method C.3 under GLP. The study was conducted under static conditions with an initial cell density of 1E4 cells/mL for a period of 72 hours. A limit test with one test concentration of 100 mg/L, and control was performed. The measured concentrations of the test item at the start and at the end of the test were in the range of 95 - 102 % of the nominal concentration. The measured concentrations deviated not more than ± 20 % from the nominal concentration, therefore, the nominal concentration was used to determine the biological results. The EC50-values for inhibition of growth rate (ErC50) and for inhibition of yield (EyC50) were >100 mg/L. The ErC10 and EyC10 values were determined to be >100 mg/L. The NOEC was determined to be 100 mg/L.
Reference
Preliminary Range-Finding Test
Table 1: Results of the preliminary range-finding test
Nominal concentrations [mg/L] |
Untreated control |
100.0 |
Average cell number |
97.67 |
92.00 |
Growth Rates (µ) [0 - 72 h] |
0.0636 |
0.0627 |
% Inhibition of µ [0 - 72 h] |
– |
1.42 |
Yield (Y) [0 - 72 h] |
96.67 |
91.00 |
% Inhibition of Y [0 - 72 h] |
– |
5.86 |
No toxic effect was observed during the preliminary test, therefore, only one test concentration (100 mg/L nominal) and one control group were tested in a limit test.
Analytical Results
The concentration of the test item was analytically determined at the start and at the end of the test. The mean of the measured concentrations was 95 % of the nominal at the start and 102 % of the nominal at the end of the test. The measured concentrations were within ± 20 % during the experiment. Therefore, the biological results are based on the nominal concentration.
Biological Results
A limit test was performed and no toxic effects were observed, therefore, statistical analysis was not necessary. The LOEC, NOEC and the ECx values were given directly from the raw data.
Average Specific Growth Rate
The 72-h NOEC based on growth rate was determined to be 100 mg/L, while the 72-h LOEC based on growth rate was determined to be > 100 mg/ L. The 72-h EC10, EC20 and EC50 values were determined to be > 100 mg/ L.
Table 2: Growth Rates (µ) and Percentage Inhibition of µ during the Test Period
Nominal Concentration |
Growth Rates (µ) and % Inhibition of µ |
|||||
0 – 24 h |
0 – 48 h |
0 – 72 h |
||||
µ |
% |
µ |
% |
µ |
% |
|
Control |
0.0297 |
- |
0.0579 |
- |
0.0582 |
- |
100 |
0.0345 |
-16.2 |
0.0568 |
1.9 |
0.0577 |
0.9 |
Remark: negative inhibition means growth stimulation
Yield
The 72-h NOEC based on yield was determined to be 100 mg/L, while the 72-h LOEC based on yield was determined to be > 100 mg/ L. The 72-h EC10, EC20 and EC50 values were determined to be > 100 mg/ L.
Table 3: Yield (Y) and Percentage Inhibition of Y during the Test Period
Nominal Concentration |
Yield (y) and % Inhibition of y |
|
0 – 72 h |
||
y |
% |
|
Control |
65.8 |
- |
100 |
64.2 |
2.5 |
Morphological Changes of Algal Cells
No abnormal shape of algal cells was noticed in the control and at the test item concentration (100 mg/L nominal) during the study.
Description of key information
The 72-h NOEC based on growth rate and yield was determined to be 100 mg/L, while the 72-h LOEC based on growth rate and yield was determined to be > 100 mg/L. The 72-h EC10, EC20 and EC50 values were determined to be > 100 mg/L.
Key value for chemical safety assessment
- EC10 or NOEC for freshwater algae:
- 100 mg/L
Additional information
The effect of the test item on the growth of a unicellular green algal species Raphidocelis subcapitata was determined according to OECD 201 and Regulation (EC) No. 226/2016 Method C.3 under GLP. The study was conducted under static conditions with an initial cell density of 1E4 cells/mL for a period of 72 hours. A limit test with one test concentration of 100 mg/L, and control was performed. The measured concentrations of the test item at the start and at the end of the test were in the range of 95 - 102 % of the nominal concentration. The measured concentrations deviated not more than ± 20 % from the nominal concentration, therefore, the nominal concentration was used to determine the biological results. The EC50-values for inhibition of growth rate (ErC50) and for inhibition of yield (EyC50) were >100 mg/L. The ErC10 and EyC10 values were determined to be >100 mg/L. The NOEC was determined to be 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.