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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-265-5 | CAS number: 118-61-6
- 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 2017-06-06 to 2017-06-13
- 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)
- Version / remarks:
- 2011
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Version / remarks:
- 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Initial concentrations: 0.250 - 0.790 - 2.50 - 7.90 - 25.0 - 79.0 mg/L, and a control
- Sampling method: All concentration levels and the controls were analytically verified via HPLC-DAD at the start (0 hours) and at the end of the exposure (72 hours) with algae. The highest test item concentration was analysed at the start and the end of the exposure without algae.
- Sample storage conditions before analysis: All original samples were stored at at 6 ± 2 °C. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock solution with a nominal loading of 79 mg test item/L was prepared with dilution water and stirred for 15 minutes at room temperature, 1100 rpm.Test concentrations were acquired by further dilution of the stock solution.
- Test concentrations: 0.250 - 0.790 - 2.50 - 7.90 - 25.0 - 79.0 mg/L
- Control: Six replicates (without test item) were incubated under the same conditions as the test concentrations - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Strain: KORSHIKOV, SAG 61.81
- Method of cultivation: Fresh stocks are prepared every month on Z-Agar. Light intensity amounted to 2567 - 5130 lux for 24 hours per day
ACCLIMATION
- Acclimation period: four days
- Culturing media and conditions (same as test or not): Nutrient medium Z, same as test - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Hardness:
- 0.24 mmol Ca+Mg/L
- Test temperature:
- 22.5 – 23.5 °C, with mean 23°C
- pH:
- 7.53 to 7.59 at test start and 8.08 to 8.97 at test end
- Nominal and measured concentrations:
- Nominal concentrations: 0.250 - 0.790 - 2.50 - 7.90 - 25.0 - 79.0 mg/L
Measured initial concentration: 0.242 - 0.759 - 2.33 - 7.60 - 23.8 - 76.0 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: Sterile Erlenmeyer flasks
- Material, size, headspace, fill volume: volume: 250 mL, sealed with cotton wool plugs, fill volume: 100 mL
- Initial cells density: 6839 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes, As recommended in OECD TG 201
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Photoperiod: 24 hours/day light
- Light intensity and quality: range of the measured values: 4873 to 5923 lux, mean value: 5582 Lux
EFFECT PARAMETERS MEASURED
- Determination of cell concentrations: Chlorophyll a-fluorescence
- Microscopic evaluation: at the start and the end of the incubation period;
- Physico-chemical Properties: pH-values at the start of exposure were measured in one additional replicate of each test item concentration and the control. At the end of exposure, the pH-values were measured from pooled samples of each test item concentration and the control. The room temperature was measured continuously. Light intensity was measured prior to the start of exposure.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10
- Range finding study
- Test concentrations: 0.500, 5.00, 50.0 mg/L
- Results used to determine the conditions for the definitive study: The stock solution and the dilution levels of 0.500 and 5.00 mg/L were visually clear throughout the exposure period. Growth rate inhibitions were 4%, 4%, 100% for 0.500, 5.00, 50.0 mg/L, respectively. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 7.89 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CL: 4.7 - 16.6 mg/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 9.47 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CL: 7.65-17.4 mg/L
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 2.33 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- other: growth rate and yield
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 8.68 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- other: yoield
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 5.31 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Details on results:
- - Microscopic evaluation: revealed no morphological abnormalities.
- Physicochemical Data: The environmental conditions (pH-value, room temperature, light intensity) were determined to be within the acceptable limits. The test item solutions were visually clear throughout the exposure phase.
- Chemical analysis of test item concentrations: The measured concentrations of the test item were between 93% and 101% at the start of the exposure (0 hours) and between < LOQ and 53% at the end of the exposure (72 hours). - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- EC50: most recent test: growth rate 0.435 mg/L (95% CI: 0.414-0.458), yield 0.230 mg/L (95% CI: 0.179-0.322) - Validity criteria fulfilled:
- yes
- Conclusions:
- In this study, the test item was found to inhibit the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours with the following effect values (based on measured initial test item concentrations): EC50-values for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were 9.47 mg/L and 8.68 mg/L, respectively. The EC10-values ErC10 and EyC10 were 7.89 mg/L and 5.31, respectively.
- Executive summary:
The toxicity of test item to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined according to the principles of OECD 201 and GLP to assess effect on 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. The main test was carried out with six concentrations in a geometrical series with a dilution factor of 10: 0.250 - 0.790 - 2.50 - 7.90 - 25.0 - 79.0 mg/L.
The concentrations of the test item in all test concentrations and the control were analytically verified by HPLC- DAD at the start and the end of exposure. Additionally the two highest concentration levels and the control were analytically verified via analysis of total organic carbon (TOC, according to DIN EN 1484) at the start and at the end of the exposure. The measured concentrations of test item in the fresh media (0 h) were between 93 and 97% of the nominal values. The measured concentrations in the old media (72 h) were in the range of < LOQ to 53% of the nominal values. Therefore, the evaluation based on measured initial concentrations was considered the most fitting evaluation.
In this study, the test item was found to inhibit the growth of the freshwater green alga Pseudokirchneriella subcapitata fter 72 hours with the following effect values (based on measured initial test item concentrations): EC50 -values for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were 9.47 mg/L and 8.68 mg/L, respectively. The EC10 -values ErC10 and EyC10 were 7.89 mg/L and 5.31, respectively.
Reference
Results non-GLP range finder study:
Nominal concentration (mg/l) | Growth rate inhibition (%) | Yield inhibition (%) |
50 | 100 | 100 |
5 | 4 | 18 |
0.5 | 4 | 20 |
Mean cell densities:
Measured initital test concentration (mg/L) | 0h | 24h | 48h | 72h |
76 | 6839 | n.a. | n.a. | n.a. |
23.8 | 6839 | 3729 | n.a. | n.a. |
7.6 | 6839 | 27805 | 285829 | 1885138 |
2.33 | 6839 | 42967 | 471677 | 2663220 |
0.759 | 6839 | 44515 | 482273 | 2720238 |
0.242 | 6839 | 48064 | 494414 | 2715478 |
Control | 6839 | 48920 | 50915-9 | 2832596 |
Evaluation of growth rate and yield inhibition after 72 hours:
Measured initial test item concentration [mg/L] |
Replicate No. | Growth rate [d-1] | Inhibition of growth rate [%] | Yield [cells/mL] | Inhibition of yield [%] |
76 | 1 | n.a. | 100 | n.a. | 100 |
2 | n.a. | 100 | n.a. | 100 | |
3 | n.a. | 100 | n.a. | 100 | |
Mean | (+) n.a. | 100 | (+) n.a. | 100 | |
23.8 | 1 | -0.295 | 100 | -4020 | 100 |
2 | n.a. | 100 | n.a. | 100 | |
3 | n.a. | 100 | n.a. | 100 | |
Mean | (+) n.a. | 100 | (+) n.a. | 100 | |
7.6 | 1 | 1.88 | 6 | 1922130 | 32 |
2 | 1.87 | 7 | 1850443 | 35 | |
3 | 1.87 | 7 | 1862323 | 34 | |
Mean | (+) 1.87 | 7 | (+) 1878299 | 34 | |
2.33 | 1 | 2.00 | 1 | 2731755 | 3 |
2 | 2.00 | 0 | 2755748 | 2 | |
3 | 1.97 | 2 | 2481640 | 12 | |
Mean | (+)* 1.99 | 1 | (-) 2656381 | 6 | |
0.759 | 1 | 2.00 | 0 | 2778512 | 2 |
2 | 1.99 | 1 |
2628467 |
7 |
|
3 |
2.00 |
1 |
2733218 |
3 |
|
Mean |
(-) 2.00 |
1 |
(-) 2713399 |
4 |
|
0.242 |
1 |
2.02 |
-1 |
2927094 |
-4 |
2 |
2.01 |
0 |
2829132 |
0 |
|
3 |
1.95 |
3 |
2369691 |
16 |
|
Mean |
(-) 1.99 |
1 |
(-) 2708639 |
4 |
|
Control |
1 |
2.01 |
|
2867579 |
|
2 |
2.03 |
3006213 |
|||
3 |
2.00 |
2784657 |
|||
4 |
2.01 |
2800047 |
|||
5 |
2.00 |
2718939 |
|||
6 |
2.00 |
2777108 |
|||
Mean |
2.01 |
|
2825757 |
|
n.a. = not applicable
*= statistically significant, but biologically not relevant (inhibition < 5%)
TOC content of the test media at the start and the end of the exposure:
Measured initial test item concentration [mg/L] |
TOC [mg C/L] |
|
Test start (without algae), 0 hours |
Test end (without algae), 72 hours |
|
76 |
49.4 |
34 |
23.8 |
20.5 |
12.8 |
Control |
< 2.00 |
< 2.00 |
Limit of quantification = 2.00 mg C/L
Measured Concentrations and Percentage of the Nominal Concentration of test item in Fresh Medium (0hours) and Old Medium (72hours) with Algae:
Sample |
0 hours fresh medium |
72 hours old medium |
||
Nominal concentration of the test item [mg/L] |
Meas. conc. [mg/L] |
[%] |
Meas. conc. [mg/L] |
[%] |
79.01) |
80.1 |
101 |
42.1 |
53 |
79 |
76 |
96 |
36.7 |
46 |
25.00 |
23.8 |
95 |
9.13 |
37 |
7.90 |
7.6 |
96 |
< LOQ |
|
2.50 |
2.33 |
93 |
0.119 |
5 |
0.79 |
0.759 |
96 |
< LOQ |
|
0.25 |
0.242 |
97 |
< LOQ |
|
Control |
< LOQ |
< LOQ |
Meas. Conc. = Measured concentration of the test item (dilution factor taken into account), mean value oftwo injections
%= Percentage of the nominal concentration of the test item
LOQ= Limit of quantification (0.100 mg test item/L)
1)= replicate without algae
Description of key information
ErC50 (72 h) = 9.47 mg/L (measured, Pseudokirchneriella subcapitata, OECD 201)
ErC10 (72 h) = 7.89 mg/L (measured, Pseudokirchneriella subcapitata, OECD 201)
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 9.47 mg/L
- EC10 or NOEC for freshwater algae:
- 7.89 mg/L
Additional information
The toxicity of test item to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined according to the principles of OECD 201 and GLP to assess effect on 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. The main test was carried out with six concentrations in a geometrical series with a dilution factor of 10: 0.250 - 0.790 - 2.50 - 7.90 - 25.0 - 79.0 mg/L.
The concentrations of the test item in all test concentrations and the control were analytically verified by HPLC- DAD at the start and the end of exposure. Additionally the two highest concentration levels and the control were analytically verified via analysis of total organic carbon (TOC, according to DIN EN 1484) at the start and at the end of the exposure. The measured concentrations of test item in the fresh media (0 h) were between 93 and 97% of the nominal values. The measured concentrations in the old media (72 h) were in the range of < LOQ to 53% of the nominal values. Therefore, the evaluation based on measured initial concentrations was considered the most fitting evaluation.
In this study, the test item was found to inhibit the growth of the freshwater green alga Pseudokirchneriella subcapitata fter 72 hours with the following effect values (based on measured initial test item concentrations): EC50 -values for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were 9.47 mg/L and 8.68 mg/L, respectively. The EC10 -values ErC10 and EyC10 were 7.89 mg/L and 5.31, respectively.
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.