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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 908-995-1 | 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:
- 2015-06-23 to 2015-06-26
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- All concentration levels, the pH control and the control were analytically verified via LC-MS/MS after 0 hours (start of exposure) and 72 hours (end of exposure). Separate replicates for the test item analysis at the beginning of exposure were prepared without algae. For the test item analysis after 72 hours, samples were taken out of the test replicates.
- Vehicle:
- no
- Details on test solutions:
- Stock solution
100 mg test item/L, freshly prepared with dilution water
Media preparation
Direct addition of the test item and shaking until the test item is completely dissolved.
Test concentrations
5 concentrations were tested in a geometrical series with a (nominal) dilution factor of ∜10=1.78: 10.0 - 17.8 - 31.7 - 56.4 - 100 mg/L.
Three replicates of the highest test concentration, adjusted with 1M NaOH and HCl to pH 8.1 ± 0.2, were tested under the same test conditions as the test vessels. The concentrations were based on the results of a preliminary range finding test (non-GLP).
Control
Six replicates (without test item) were exposed 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
Pseudokirchneriella subcapitata HINDÁK, SAG 61.81
Reason for the selection of the test organism
Pseudokirchneriella subcapitata is a suitable green alga species according to the guideline.
Origin Sammlung von Algenkulturen (SAG)
Pflanzenphysiologisches Institut der Universität Göttingen
Nikolausberger Weg 18, D-37073 Göttingen
Cultivation at test facility
Fresh stocks are prepared every month on Z-Agar. Light intensity amounted to 35-70 µE•m-2•s-1 for 24 hours per day.
Culture medium
Nutrient medium Z according to LÜTTGE et al. (1994) - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- No
- Hardness:
- Dilution water: 0.24 mmol Ca+mg/L.
- Test temperature:
- min.: 21.5 max.: 23.0, mean value: 22.3
- pH:
- Nominal test item concentration pH-value
[mg/L] Start; 0 hours End; 72 hours
pH-Control 8.23 7.80
100 3.60 3.42
56.4 4.76 4.39
31.7 7.15 5.91
17.8 7.59 6.27
10.0 7.80 7.13
Control 8.19 8.24 - Dissolved oxygen:
- Not measured
- Salinity:
- Not measured, freshwater conditions
- Nominal and measured concentrations:
- nominal: 10.0 - 17. 8 - 31.7 - 56.4 - 100 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL Erlenmeyer flasks
- Type (delete if not applicable): open, cotton wool plugs
- Material, size, headspace, fill volume: sterile 250 mL Erlenmeyer flasks, test volume 100 mL
- Aeration: Test containers were placed on a rotary shaker and oscillated at appr. 70 rpm
- Type of flow-through (e.g. peristaltic or proportional diluter): None
- Renewal rate of test solution (frequency/flow rate): One application at test start
- Initial cells density: Nominal: approximately 2 - 5 x 103 cells/mL, Actual: mean 6153 cells/mL
- Control end cells density: Mean 2510377 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
- Source/preparation of dilution water: Dilution water, composition acc. to the guideline
- Hardness: 0.24 mmol Ca+Mg/L
- pH-value: 8.1 +/- 0.2
- Culture medium: Nutrient Medium Z acc. to LÜTTGE et al. (1994)
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod: 24 h
- Light intensity and quality: 60 - 120 µE x m-2 x s-1, mean value: 67.2
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: [counting chamber; electronic particle counter; fluorimeter; spectrophotometer; colorimeter] fluorimeter, Cell density and self fluorescence was measured daily via Chlorophyll-a- fluorescence, excitation at 436 nm, emission at 685 nm. Dilution water was used as background signal.
TEST CONCENTRATIONS
- Range finding study:
Biological Data
The results of the range finding test are presented below:
Results of the Range Finding Test (0 - 72 hours)
Nominal Test Item Concentration [mg/L] Growth Rate Inhibition [%] Yield Inhibition [%]
100 114 100
10.0 -3 -15
1.00 -4 -26
pH-Control (100 mg/L, adjusted to 8.1) 6 30
Negative values = growth stimulation
Analytical Data
The analytical data of the range finding test are presented below:
Measured Exposure Concentrations during the non GLP Preliminary Range Finding Test
Determination of the test item via LC-MS/MS, with a preliminary non validated analytical method
Sampling time 0 h 72 h
Test item Meas. Meas. Recovery
concentration conc. Recovery conc. [%]
[mg/L] [mg/L] [%] [mg/L]
10.0 9.80 98 10.5 105
Meas. conc = Measured concentration of the test item, dilution factor taken into account - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- < 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 27.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 23.0 - 30.9
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- 31.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 27.3 - 31.7
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 35.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 32.8 - 44.3
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- < 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- < 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- < 10 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 20.9 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Remarks on result:
- other: 19.3 - 22.6
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test):
- Unusual cell shape: No
- Colour differences: No
- Flocculation: No
- Adherence to test vessels: No
- Aggregation of algal cells: No
- Other: No
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
The toxicity of potassium dichromate (SIGMA, batch number MKBQ9179V, purity 100 %, CAS RN 7778-50-9) to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined over a period of 72 hours from 2015-04-14 to 2015-04-17 (with headspace). The reference item toxicity is in the valid range following test facility SOPS. For results, see Table 10.
EC50-Values of the Reference Item based on nominal concentrations mg/L, (0-72 hours)
Current Study Valid Range (average ± 3 x SD)
Growth Rate inhibition
ErC50 0.613 0.810 ± 0.404
95 % confidence interval 0.589 - 0.638
Yield inhibition
EyC50 0.281 0.421 ± 0.274
95 % confidence interval 0.234 - 0.314
SD = Standard deviation - Reported statistics and error estimates:
- EC-values and statistical analyses
EC10-, EC20- and EC,50-values with confidence intervals of growth rate and yield inhibition after 72 hours were calculated by sigmoidal dose-response regression.
NOEC, LOEC and statistical analyses
The NOEC and LOEC were determined by calculation of statistically significant differences of growth rates and yield. As a standard, One Way Analysis of Variance (ANOVA) and DUNNETT’s test were used for NOEC/LOEC 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 -value (acceptable probability of incorrectly concluding that there is a difference) is =0.05.
Software
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, Hordaphos CC MIS was found not to inhibit the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours when tested with 100 mg/L and a pH adjusted to 8.1. The NOEC (0-72 h) for both inhibition of growth and inhibition of yield was 100 mg/L.As the toxic effects are due to the pH value this was additionally investigated in a geometrical series of five test concentrations. Under these conditions, the following effect values were determined: The EC50-values with 95 % confidence intervals for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were 35.3 (32.8 – 44.3) mg/L and 20.9 (19.3 – 22.6) mg/L, respectively. The NOEC-values for inhibition of both growth rate and yield after 72 hours were < 10.0 mg/L. All effect values are based on the nominal concentrations of Hordaphos CC MIS.
- Executive summary:
The toxicity of Hordaphos CC MIS (Batch no.: DEH2 035729) to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined according to the principles of OECD 201 andCouncil Regulation (EC) No. 761/2009/Method C.3 from 2015-06-23 to 2015-06-26 at Dr.U.Noack-Laboratorien in 31157 Sarstedt, Germany. 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 6153 cells/mL. A stock solution of 100 mg/L was freshly prepared with dilution water. In the range finding test, it was observed that the toxic effect of Hordaphos CC MIS is due to the pH of the test solutions. Therefore, a limit test concentration of 100 mg/L was tested with a pH value adjusted to 8.1. Additionally, the influence of the pH value was investigated in a geometrical series of five test concentrations with a dilution factor of (nominal):10.0 - 17. 8 - 31.7 - 56.4 - 100 mg/L. The environmental conditions were within the acceptable limits.
The test media were visually clear throughout the test period. The concentrations of the test item Hordaphos CC MIS in all test concentrations and the control were analytically verified by LC-MS/MS at the start and the end of exposure.
The measured concentrations of Hordaphos CC MIS in the fresh media (0 h) were in the range of 97 to 112 % of the nominal values at all tested concentration levels. The measured concentrations in the old media (72 h) were in the range of 106 to 110 % of the nominal values of all concentrations.Therefore, all effect values given are based on the nominal test item concentrations of Hordaphos CC MIS.
The two highest concentrations caused a change of the pH value to be below 5. The toxic effects are due to the pH value. Replicates with the test item concentration of 100 mg/L adjusted to pH 8.1 showed no toxic effects.
NOEC, LOEC, EC-values and 95 % Confidence Intervals of HordaphosCC MIS (0 - 72 hours)
based on nominal test item concentrations [mg/L]
Not pH-Neutralized
pH-Neutralized
Growth RateInhibition
Growth RateInhibition
NOEC
< 10.0
100
LOEC
10.0
> 100
ErC10
27.8 (23.0 – 30.9)
> 100
ErC20
31.3 (27.3 – 31.7)
> 100
ErC50
35.3 (32.8 – 44.3)
> 100
Inhibition of Yield
Inhibition of Yield
NOEC
< 10.0
< 100
LOEC
10.0
100
EyC10
< 10.0
< 100
EyC20
< 10.0
> 100
EyC50
20.9 (19.3 – 22.6)
> 100
Reference
Cell Densities
Nominal test item concentration |
Replicate |
Cell density [cells/mL] |
|||||||||
[mg/L] |
No. |
0 hours |
24 hours |
48 hours |
72 hours |
||||||
100 mg/L |
1 |
6153 |
31733 |
393211 |
2270075 |
||||||
2 |
6153 |
42389 |
400549 |
2226924 |
|||||||
3 |
6153 |
32436 |
449345 |
2173612 |
|||||||
Mean |
6153 |
35519 |
414368 |
2223537 |
|||||||
100 |
1 |
6153 |
<LOQ |
3409 |
4340 |
||||||
2 |
6153 |
3588 |
3644 |
<LOQ |
|||||||
3 |
6153 |
3033 |
<LOQ |
<LOQ |
|||||||
Mean |
6153 |
n.a. |
n.a. |
n.a. |
|||||||
56.4 |
1 |
6153 |
3534 |
<LOQ |
<LOQ |
||||||
2 |
6153 |
3525 |
4055 |
<LOQ |
|||||||
3 |
6153 |
3754 |
3776 |
3503 |
|||||||
Mean |
6153 |
3604 |
n.a. |
n.a. |
|||||||
31.7 |
1 |
6153 |
43123 |
414504 |
681252 |
||||||
2 |
6153 |
39100 |
328358 |
632299 |
|||||||
3 |
6153 |
41270 |
347895 |
673381 |
|||||||
Mean |
6153 |
41164 |
363586 |
662311 |
|||||||
17.8 |
1 |
6153 |
49138 |
552927 |
1358064 |
||||||
2 |
6153 |
43929 |
401803 |
1459168 |
|||||||
3 |
6153 |
35412 |
319797 |
1459796 |
|||||||
Mean |
6153 |
42826 |
424842 |
1425676 |
|||||||
10.0 |
1 |
6153 |
46984 |
423881 |
1767375 |
||||||
2 |
6153 |
33969 |
355328 |
1994609 |
|||||||
3 |
6153 |
33496 |
339805 |
1772518 |
|||||||
Mean |
6153 |
38150 |
373005 |
1844834 |
|||||||
Control |
1 |
6153 |
55034 |
605518 |
2615349 |
||||||
2 |
6153 |
51895 |
538658 |
2602742 |
|||||||
3 |
6153 |
47294 |
464178 |
2294850 |
|||||||
4 |
6153 |
45127 |
442540 |
2902983 |
|||||||
5 |
6153 |
33737 |
375461 |
2095526 |
|||||||
6 |
6153 |
45767 |
427581 |
2550810 |
|||||||
Mean |
6153 |
46476 |
475656 |
2510377 |
< LOQ = below the limit of quantification (2736 cells/mL) n.a. = data not determinable
Evaluation after 72 hours
Statistically significant differences of growth rates and yield compared to control values are marked (+), not significant differences are marked (-).
Nominal test item concentration |
Replicate |
Growth rate |
Inhibition of growth rate |
Yield |
Inhibition of yield |
||
[mg/L] |
No. |
[d-1] |
[%] |
[cells/mL] |
[%] |
||
100 mg/L |
1 |
|
1.97 |
2 |
|
2263922 |
10 |
2 |
|
1.96 |
2 |
|
2220771 |
11 |
|
3 |
|
1.96 |
2 |
|
2167459 |
13 |
|
Mean |
(-) |
1.96 |
2 |
(-) |
2217384 |
11 |
|
100 |
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 |
|
56.4 |
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 |
|
31.7 |
1 |
|
1.57 |
22 |
|
675099 |
73 |
2 |
|
1.54 |
23 |
|
626146 |
75 |
|
3 |
|
1.57 |
22 |
|
667228 |
73 |
|
Mean |
(+) |
1.56 |
22 |
(+) |
656158 |
74 |
|
17.8 |
1 |
|
1.80 |
10 |
|
1351911 |
46 |
2 |
|
1.82 |
9 |
|
1453015 |
42 |
|
3 |
|
1.82 |
9 |
|
1453643 |
42 |
|
Mean |
(+) |
1.82 |
9 |
(+) |
1419523 |
43 |
|
10.0 |
1 |
|
1.89 |
6 |
|
1761222 |
30 |
2 |
|
1.93 |
4 |
|
1988456 |
21 |
|
3 |
|
1.89 |
6 |
|
1766365 |
29 |
|
Mean |
(+) |
1.90 |
5 |
(+) |
1838681 |
27 |
|
Control |
1 |
|
2.02 |
|
|
2609196 |
|
2 |
|
2.02 |
|
|
2596589 |
|
|
3 |
|
1.97 |
|
|
2288697 |
|
|
4 |
|
2.05 |
|
|
2896830 |
|
|
5 |
|
1.94 |
|
|
2089373 |
|
|
6 |
|
2.01 |
|
|
2544657 |
|
|
Mean |
|
2.00 |
|
|
2504224 |
|
Description of key information
In this study, Hordaphos CC MIS was found not to inhibit the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours when tested with 100 mg/L and a pH adjusted to 8.1. The NOEC (0-72 h) for both inhibition of growth and inhibition of yield was 100 mg/L.
As the toxic effects are due to the pH value this was additionally investigated in a geometrical series of five test concentrations. Under these conditions, the following effect values were determined: The EC50-values with 95 % confidence intervals for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were 35.3 (32.8 – 44.3) mg/L and 20.9 (19.3 – 22.6) mg/L, respectively. The NOEC-values for inhibition of both growth rate and yield after 72 hours were < 10.0 mg/L. All effect values are based on the nominal concentrations of Hordaphos CC MIS.
Key value for chemical safety assessment
Additional information
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.