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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 605-495-2 | CAS number: 167948-98-3
- 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:
- 2018-08-10 till 2018-12-13
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- At the start of the exposure (0 hours), samples of the fresh media were taken after preparation of each concentration and analyzed. At the end of the exposure (72 hours), samples of the old media were taken from the test vessels for analyses.
- Vehicle:
- no
- Details on test solutions:
- A saturated solution with a nominal loading of 10.0 mg test item/L was freshly prepared prior to the start of the exposure. An appropriate amount of the test item was weighed out and transferred with an appropriate amount of the dilution water into the glass flask. This dispersion was treated with ultrasound for 60 minutes at room temperature. Thereafter, the saturated solution was removed by siphoning from the middle of the flask. The saturated solution was checked via laser beam (Tyndall effect) for undissolved test item. The Tyndall effect was negative.
- Test organisms (species):
- Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Green algae
- Strain: HINDAK, CCAP 278/4
- Source: Culture Collection of Algae and Protozoa (CCAP), SAMS Research Services Ltd, Dunstaffnage Marine Laboratory, Dunbeg, OBAN; Argyll PA37 1QA; Scotland, UK
- Method of cultivation: On Z-Agar
ACCLIMATION
- Acclimation period: no
- Culturing media and conditions: same as test conditions - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 23 - 24°C
- pH:
- 7.82 - 9.38
- Nominal and measured concentrations:
- Nominal concentrations: 0.1, 0.316, 1, 3.16 and 10 mg/L
Geometric mean measured concentration: 10, 28.4, 113, 417 and 1423 µg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer flasks
- Type: closed with cotton wool plugs
- Material, fill volume: glass, 250 mL
- Aeration: no
- Initial cells density: 6442 cells/mL
- Control end cells density: 1531776 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: According to the guideline OECD 201
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Photoperiod: 24 hours/day light
- Light intensity: 5286 to 6432 lux
EFFECT PARAMETERS MEASURED
Determination of cell concentrations: Chlorophyll a-fluorescence, excitation at 436 nm, emission at 685 nm measured daily
Microscopic evaluation of the cells at the start and the end of the incubation period was carried out.
The pH-values at the start of exposure were measured in one additional replicate of each concentration level and the control. At the end of exposure, the pH-values were measured from pooled samples of the test item concentrations 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: 0.1, 1, 3, 10 mg/L
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 250 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 61.6 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 66.1 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 12.6 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 10 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Growth rate and yield
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 28.4 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Growth rate and yield
- Details on results:
- The study meets the validity criteria of the guideline:
- The required increase of the cell growth in the control cultures was exponentially (> 16-fold corresponding to a specific growth rate of 0.92 day-1), in this study the increase was 238-fold (specific growth rate 1.82 day-1).
- Mean coefficients of variation for section-by-section specific growth rates (days 0-1, 1-2 and 2-3) in the control cultures should be < 35%, in this study the coefficient was 25.5%.
- Coefficient of variation of average specific growth rates during the whole test period in replicate control cultures should be < 7%, in this study the coefficient was 1.70%.
Microscopic evaluation of the cells at the start and end of exposure revealed no morphological abnormalities. All effect values are given based on the nominal test item concentrations. - Results with reference substance (positive control):
- The toxicity of potassium dichromate (SIGMA ALDRICH, batch number MKBV0900V, purity 99.0%, CAS RN 7778-50-9) to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined over a period of 72 hours from 2018-03-26 to 2018-03-29. The reference item toxicity is in the valid range following test facility SOPs. The measured EC50 based on growth rate inhibition was 1.09 (95% confidence interval: 0.842-1.31), the EC50 based on yield was 0.548 (95% confidence interval: 0.439 - 0.660).
- Reported statistics and error estimates:
- EC10-, EC20- and ECso-values with confidence intervals of growth rate and yield inhibition after 72 hours were calculated by sigmoidal dose-response regression. The NOEC and LOEC were determined by calculation of statistical significant differences of growth rates and yield. As a standard, One Way Analysis of Variance (ANOVA) and DUNNETT'S test were used for NOEL/LOEL calculations. When running a One Way Analysis of Variance, a Normality test and an Equal Variance test were done first. P-values for both Normality and Equal Variance tests are 0.05. The a-value (acceptable probability of incorrectly concluding that there is a difference) is a=0.05. Equal Variance test failed for calculation of growth rate. Therefore, data were transformed (Y=10Y). The data for the tables in this report were computer-generated and have been rounded for presentation from the full derived data. Consequently, if calculated manually based on the given data minor deviations may occur from these figures. Calculations were carried out using software:
• Excel, MICROSOFT CORPORATION
• SigmaPlot, SPSS INC.
• GraphPad Prism, GRAPHPAD SOFTWARE, INC - Validity criteria fulfilled:
- yes
- Conclusions:
- In this study, the effect values of the test item on the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours were determined as follows (based on geometric mean measured test item concentrations): The EC50-values for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were 250 µg/L and 66.1 µg/L, respectively. The EC10 value for inhibition of growth rate was 61.6 µg/L.
- Executive summary:
The toxicity of the test item to the unicellular freshwater green algaPseudokirchneriella subcapitatawas determined according to the principles of OECD 201 and Council Regulation (EC) No. 266/2016/Method C.3 at the test facility. The aim of the study was the determination of the effects on growth rate and yield over a period of 72 hours. The study was conducted under static conditions with an initial cell density of 6442 cells/mL. A saturated solution with a nominal loading of 10.0 mg/L was prepared with dilution water. Out of the saturated solution five concentration levels were tested in a geometrical series with a dilution factor of: 1.00 – 3.16 - 10.0 - 31.6 - 100%. Three replicates were tested for each test item concentration level and six replicates for the control. The environmental conditions were within the acceptable limits. The initially measured concentrations of the test item were 15.4 - 36.4 - 128 -476 - 1319 µg/L At the end of exposure after 72 hours, the measured concentrations were in the range of < LOQ to 116% of the initially measured concentrations. The geometric mean measured test item concentrationswere calculated to be10.0 - 28.4 - 113 - 417 - 1423 µg/L. The following effect values were calculated ((based on geometric mean measured test item concentrations): The EC50-values for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were 250 (231 - 291) µg/L and 66.1 (50.2 - 83.5) µg/L, respectively. The EC10 value for inhibition of growth rate was 61.6 µg/L.
Reference
Table 1: Measured Concentration of the test item in the definitive test with Algae
Sampling date |
Fresh Media, 0 hours |
Old Media, 72 hours |
Geometric mean measured concentration of the test item [ug/L] |
|
Dilution level of the saturated solution [%] |
Test item |
|||
Meas. cone. [µg/L] |
Meas. cone. [µg/L] |
% |
||
100 |
1319 |
1534 |
116 |
1423 |
31.6 |
476 |
365 |
77 |
417 |
10.0 |
128 |
97.7 |
77 |
113 |
3.16 |
36.4 |
21.9 |
61 |
28.4 |
1.00 |
< LOQ (15.4) |
< LOQ (5.77) |
37 |
10.0*) |
Control |
< LOQ |
<LOQ |
|
Meas. cone. = measured concentration of the test item, enrichment and dilution factors taken into account
% = percent of the initially measured concentration of the test item
LOQ = limit of quantification (20µg/L of the test item)
*) = for geometric mean % LOQ (10µg/L of the test item) taken in lo account
Table 2: Cell densities
Geometric mean measured test item concentration [µg/L] |
|
|
|
|
|
Replicate |
|
Cell density [cells/mL] |
|
||
|
|
|
|||
No. |
0 hours |
24 hours |
48 hours |
72 hours |
|
|
1 |
6442 |
6924 |
4513 |
<LOQ cell density |
1423 |
2 |
6442 |
7115 |
6159 |
2837 |
3 |
6442 |
6646 |
5583 |
3038 |
|
|
Mean |
6442 |
6895 |
5418 |
n.a. |
|
1 |
6442 |
9731 |
12864 |
19994 |
417 |
2 |
6442 |
10980 |
13093 |
26019 |
3 |
6442 |
9332 |
17747 |
55114 |
|
|
Mean |
6442 |
10014 |
14568 |
33709 |
|
1 |
6442 |
14987 |
60903 |
314987 |
113 |
2 |
6442 |
14885 |
87764 |
538884 |
3 |
6442 |
15007 |
92272 |
641039 |
|
|
Mean |
6442 |
14960 |
80313 |
498303 |
|
1 |
6442 |
17114 |
144236 |
1009442 |
28.4 |
2 |
6442 |
19383 |
143014 |
1227355 |
3 |
6442 |
22889 |
150735 |
1242648 |
|
|
Mean |
6442 |
19795 |
145995 |
1159815 |
|
1 |
6442 |
23177 |
192749 |
1512992 |
10.0 |
2 |
6442 |
18730 |
193275 |
1284403 |
3 |
6442 |
21625 |
177864 |
1458129 |
|
|
Mean |
6442 |
21177 |
187963 |
1418508 |
|
1 |
6442 |
26170 |
217981 |
1482258 |
|
2 |
6442 |
22278 |
225994 |
1660403 |
|
3 |
6442 |
21523 |
209729 |
1615420 |
Control |
4 |
6442 |
26205 |
230145 |
1301086 |
|
5 |
6442 |
25105 |
247294 |
1482705 |
|
6 |
6442 |
24793 |
234792 |
1648785 |
|
Mean |
6442 |
24346 |
227656 |
1531776 |
LOQ cell density = 2653 N/mL; n.a. = not available
Table 3: Evaluation after 72 hours: Statistically significant differences of growth rates and yield compared to control values are marked (+), not significant differences are marked (-).
Geometric mean measured test item concentration |
Replicate |
Growth Rate |
Inhibition of Growth Rate |
Yield |
Inhibition of Yield |
|
[µg/L] |
No. |
|
[d-1] |
[%] |
[cells/mL] |
[%] |
|
1 |
|
n.a. |
100 |
n.a. |
100 |
1423 |
2 |
|
-0.27 |
100 |
-3605 |
100 |
|
3 |
|
-0.25 |
100 |
-3404 |
100 |
|
Mean |
|
(+) n.a. |
100 |
(+) n.a. |
100 |
|
1 |
|
0.38 |
79 |
13552 |
99 |
|
2 |
|
0.47 |
74 |
19577 |
99 |
417 |
3 |
|
0.72 |
61 |
48672 |
97 |
|
Mean |
|
(+) 0.52 |
72 |
(+) 27267 |
98 |
|
1 |
|
1.30 |
29 |
308545 |
83 |
|
2 |
|
1.48 |
19 |
532442 |
65 |
113 |
3 |
|
1.53 |
16 |
634597 |
58 |
|
Mean |
|
(+) 1.44 |
21 |
(+) 491861 |
68 |
|
1 |
|
1.69 |
8 |
1003000 |
34 |
|
2 |
|
1.75 |
4 |
1220913 |
20 |
28.4 |
3 |
|
1.75 |
4 |
1236206 |
19 |
|
Mean |
|
(+) 1.73 |
5 |
(+) 1153373 |
24 |
|
1 |
|
1.82 |
0 |
1506550 |
1 |
|
2 |
|
1.77 |
3 |
1277961 |
16 |
10.0 |
3 |
|
1.81 |
1 |
1451687 |
5 |
|
Mean |
|
(-) 1.8 |
1 |
(-) 1412066 |
7 |
|
1 |
|
1.81 |
|
1475816 |
|
|
2 |
|
1.85 |
|
1653961 |
|
|
3 |
|
1.84 |
|
1608978 |
|
|
4 |
|
1.77 |
|
1294644 |
|
|
5 |
|
1.81 |
|
1476263 |
|
Control |
6 |
|
1.85 |
|
1642343 |
|
|
Mean |
1.82 |
|
1525334 |
|
n.a. = not available
Description of key information
The effect values of the test item on the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours were determined as follows (based on geometric mean measured test item concentrations): The EC50-values for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were 250 µg/L and 66.1 µg/L, respectively. The EC10 value for inhibition of growth rate was 61.6 µg/L (reference 6.1.5 -1).
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 0.25 mg/L
- EC10 or NOEC for freshwater algae:
- 61.6 µg/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/Method C.3 at the test facility. The aim of the study was the determination of the effects on growth rate and yield over a period of 72 hours. The study was conducted under static conditions with an initial cell density of 6442 cells/mL. A saturated solution with a nominal loading of 10.0 mg/L was prepared with dilution water. Out of the saturated solution five concentration levels were tested in a geometrical series with a dilution factor of: 1.00 – 3.16 - 10.0 - 31.6 - 100%. Three replicates were tested for each test item concentration level and six replicates for the control. The environmental conditions were within the acceptable limits.The initially measured concentrations ofthe test itemwere 15.4 - 36.4 - 128 -476 - 1319 µg/L At the end of exposure after 72 hours, the measured concentrations were in the range of < LOQ to 116% of the initially measured concentrations. The geometric mean measured test item concentrationswere calculated to be10.0 - 28.4 - 113 - 417 - 1423 µg/L. The following effect values were calculated ((based on geometric mean measured test item concentrations): The EC50-values for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were 250 (231 - 291) µg/L and 66.1 (50.2 - 83.5) µg/L, respectively. The NOEC for both inhibition of growth rate and yield were 10.0 µg/L, respectively (reference 6.1.5 -1).
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.