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EC number: - | 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:
- 2018-10-03 to 2018-11-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- Adopted March 23, 2006; Annex 5 corrected 28 July 2011.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 23, Guidance document on aquatic toxicity testing of difficult substances and mixtures
- Version / remarks:
- 2000
- Deviations:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Frequency:
At the start (t=0 h), after 24 h and the end of the test (t= 72 h).
Concentrations:
Samples for analysis were taken from all concentrations and the control, immediately before transfer to the individual replicates. Care was taken not to include any floating layer, test item film or undissolved material in separate vessels. At the end of the test, samples were taken from the approximate center of the pooled solutions of the vessels containing the algal suspensions at each concentration.
Number of samples:
Sampling consisted of single samples per treatment. Additionally, samples were taken from the additional vessels without algae.
Volume:
2 mL per sample;
Storage:
Samples were stored in a freezer (=-15°C) until analysis - Vehicle:
- no
- Details on test solutions:
- Water Accommodated Fractions were prepared:
Individual loading rates were vigorously agitated on a magnetic stirrer for 6 days. On day 3 of stirring, pH was measured in case adjustment would be necessary (no adjustment was necessary: pH of 8.0 ± 0.3). After 6 days of stirring, the obtained mixtures were allowed to settle for 1 day in order to allow separation of phases. Thereafter, the aqueous Water Accommodated Fractions (WAFs) were collected by means of siphoning over glasswool (put into a funnel). Glasswool filtering to avoid a positive Tyndall effect was necessary only in the range-finding test. In this case, glasswool was pre-saturated with the test item beforehand. No Tyndall effect was observed in any prepared solution, and solutions were clear and colourless at the end of the preparation procedure.
Thereafter, the aqueous WAFs were used as test concentrations.
Based on preliminary results, the period of 6 days of stirring was used to ensure that
a) Concentration of the relevant transition metal stabilizes at the pH 8.0 ± 0.3 used for ecotoxicity testing to prevent any precipitation during the test;
b) Saturation of the aquatic phase with organic hydrolysis products stemming from aromatic phosphites is obtained. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Species: Raphidocelis subcapitata (formerly known as Pseudokirchneriella subcapitata)
Source: In-house laboratory culture.
Reason for selection: This system is a unicellular algal species sensitive to toxic items in the aquatic ecosystem and has been selected as an internationally accepted species.
FRESH WATER ALGAE CULTURE
Stock culture:
Algae stock cultures are started by inoculating growth medium with algal cells from a pure culture on agar. The suspensions are continuously aerated and exposed to light in a climate room at a temperature of 21-24°C.
Light intensity:
60 to 120 µE/m2/s when measured in the photosynthetically effective wavelength range of 400 to 700 nm.
Stock culture medium:
M1; according to the NPR 6505, formulated using Milli-RO water and with the following composition:
NaNO3: 500 mg/L
K2HPO4: 39.5 mg/L
MgSO4.7H2O: 75 mg/L
Na2CO3: 20 mg/L
C6H8O7.H2O: 6 mg/L
NH4NO3: 330 mg/L
CaCl2.2H2O: 35 mg/L
C6H5FeO7.xH2O: 6 mg/L
H3BO3: 2.9 mg/L
MnCl2.4H2O: 1.81 mg/L
ZnCl2: 0.11 mg/L
CuSO4.5H2O: 0.08 mg/L
(NH4)6Mo7O24.4H2O: 0.018 mg/L
Pre-culture:
2 to 4 days before the start of the test, cells from the algal stock culture are inoculated in culture medium at a cell density of 1 x 10^4 cells/mL. The pre-culture is maintained under the same conditions as used in the test. The cell density is measured immediately before use.
Pre-culture medium:
M2; according to the OECD 201 Guideline (OECD medium), formulated using Milli-RO water.
Hardness (Ca+Mg): 0.24 mmol/L (24 mg CaCO3/L)
pH 8.1 ± 0.2 - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- no
- Hardness:
- Hardness (Ca+Mg): 0.24 mmol/L (24 mg CaCO3/L)
- Test temperature:
- 22 +/- 1 °C
- pH:
- 8.0 ± 0.3
- Dissolved oxygen:
- not applicable
- Salinity:
- not applicable
- Nominal and measured concentrations:
- For the initial range-finding and the final test, the following water accommodated fractions
(WAF, based on nominal loading rate) were individually prepared:
1.0 mg/L; 10 mg/L; 100 mg/L (ranage finding test);
1.0, 3.2, 10, 32, 100 mg/L (final test).
Please see IUCLID section "Any other information on results incl. tables" below for information on analytical results. - Details on test conditions:
- Please see IUCLID section "Any other information on materials and methods incl. tables" below for details.
- Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Remarks:
- Based on Water Accommodated Fraction (WAF) approach
- Effect conc.:
- 12.4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- 95% CI: 11.8-13.2
- Duration:
- 72 h
- Dose descriptor:
- EL10
- Remarks:
- Based on Water Accommodated Fraction (WAF) approach
- Effect conc.:
- 5.9 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks:
- 95% CI: 5.3-6.6
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Remarks:
- Based on Water Accommodated Fraction (WAF) approach
- Effect conc.:
- 3.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: Based on biological relevance
- Details on results:
- See IUCLID section "Any other information on results incl. tables" for details.
- Results with reference substance (positive control):
- The effect concentrations obtained for potassium dichromate were in the valid range.
- Reported statistics and error estimates:
- See IUCLID section "Any other information on materials and methods incl. tables" for details.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The toxicity to freshwater green algae was tested according to OECD 201 compliant with GLP. Due to the nature of Step 2 catalyst (UVCB), according to OECD 23 water accommodated fractions
(WAF) were prepared.
Results:
NOELR (Pseudokirchneriella subcapitata; 72 h; static; growth rate) = 3.2 mg/L;
EL10 (Pseudokirchneriella subcapitata; 72 h; static; growth rate) = 5.9 mg/L (95% CI: 5.3-6.6)
EL50 (Pseudokirchneriella subcapitata; 72 h; static; growth rate) = 12.4 mg/L (95% CI: 11.8-13.2) - Executive summary:
The toxicity to freshwater green algae was tested according to OECD 201 compliant with GLP. The test organism was Pseudokirchneriella subcapitata. Due to the nature of Step 2 catalyst (UVCB), according to OECD 23 water accommodated fractions (WAF) were prepared and based on the results of a range finding tests (significant effects observed at WAF 10 and 100 mg/L) the final test was conducted at WAFs were prepared at 1.0, 3.2, 10, 32 and 100 mg/L nominal loading: individual loading rates were vigorously agitated on a magnetic stirrer for 6 days. Based on preliminary results, the period of 6 days of stirring was used to ensure that
a) Concentration of the relevant transition metal stabilizes at the pH 8.0 ± 0.3 used for ecotoxicity testing to prevent any precipitation during the test;
b) Saturation of the aquatic phase with organic hydrolysis products stemming from aromatic phosphites is obtained.
The presence of any non-dissolved test item fraction could be excluded before testing by measuring the Tyndall effect.
Analytical monitoring was performed for the relevant transition metal (ICP-MS) as well as the organic fraction (UPLC-UV at 210 nm). At WAF 1 mg/L and 100 mg/L transition metal concentration was stable over the 72 hours of the test. Step 2 catalyst concentration equivalent of 0.37 and 23.1 mg/L, respectively, was found in freshly prepared WAF (after 6 days of stirring and one day settling period). For WAF 1 mg/L, 92% of this initial concentration was recovered after 24 and 72 hours (0.34 mg/L). For WAF 100 mg/L, 100% and 103% of the initial concentration was recovered after 24 and 72 hours (23.2 / 23.7 mg/L). This is equivalent to transition metal concentrations of ca. 3 µg/L for WAF 1 mg/L and ca. 190 µg/L for WAF 100 mg/L.
With regard to the organics fraction monitored via UPLC-UV at 210 nm, initial Step 2 catalyst concentration equivalents of 1.86 mg/L and 221 mg/L were measured for WAF 1 and WAF 100 mg/L, respectively. Over the time course of the study (72 h) there was a relevant decline to 2.7 % of initial for WAF 1 mg/L and 0.2% of initial for WAF 100 mg/L. The reason for this decline is not clear. In the corresponding test for acute toxicity on Daphnia and fish an increase of absorption at 210 nm was observed. The decrease over time observed here could be either due to adsorption to algal biomass and/or further abiotic transformations (hydrolysis / oxidation) to molecular species with different chromatographic elution time / different absorption maxima during the test. The results confirm in any case that WAF preparation succeeded in a relevant organic fraction present at least at the beginning of the test.
The following results were obtained in the final test (based on growth rate inhibition):
NOELR (Pseudokirchneriella subcapitata; 72 h; static; growth rate) = 3.2 mg/L;
EL10 (Pseudokirchneriella subcapitata; 72 h; static; growth rate) = 5.9 mg/L (95% CI: 5.3-6.6)
EL50 (Pseudokirchneriella subcapitata; 72 h; static; growth rate) = 12.4 mg/L (95% CI: 11.8-13.2)
Reference
These data are based on results from draft report and will be amended as soon as the final report will have been issued.
Details on Biological Data:
Range-finding test - growth rate
Treatm. [waf mg/L] |
Mean growth rate [/d] |
Std. Dev. |
n |
%Inhibition |
Control |
2.010 |
0.0129 |
6 |
|
1.0 |
1.991 |
0.0264 |
3 |
0.96 |
10 |
1.186 |
0.0533 |
3 |
41 |
100 |
0.520 |
0.0725 |
6 |
74 |
At the highest test item concentration (WAF 100 mg/L) turbidity was observed. Based on these effect data, a full final test was performed.
Final Test
A) GROWTH RATE
Treatm. [waf mg/L] |
Mean growth rate [/d] |
Std. Dev. |
n |
%Inhibition |
Control |
1.776 |
0.0278 |
6 |
|
1.0 |
1.722 |
0.0299 |
3 |
3.0 |
3.2 |
1.711 |
0.0363 |
3 |
3.7 |
10 |
1.154 |
0.1295 |
3 |
35 |
32 |
0.081 |
0.0706 |
3 |
95 |
100 |
0.000 |
0.0000 |
3 |
100 |
B) YIELD
Treatm. [waf mg/L] |
Mean |
Std. Dev. |
n |
%Decrease |
Control |
205.7 |
17.11 |
6 |
|
1.0 |
174.6 |
16.07 |
3 |
15 |
3.2 |
169.0 |
18.63 |
3 |
18 |
10 |
32.4 |
11.41 |
3 |
84 |
32 |
0.3 |
0.26 |
3 |
100 |
100 |
0.0 |
0.00 |
3 |
100 |
For WAF preparation, no glasswool was used since none of the test solutions were hazy before siphoning. All test solutions were clear and colorless at the end of the preparation procedure. No Tyndall effect was observed in any prepared solution. At the end of preparation, pH was measured and was within the limits as described in the Study Plan (pH of 8.0 ± 0.3).
At the end of the test, all validity criteria as described in the study plan were met. A concentration-related increase of growth rate and yield inhibition was observed.
RESULTS OF STATISTICAL EVALUATION
The following effect parameters were determined using ToxRat Professional (ToxRat Solutions®, GmbH, Germany):
Parameter (mg/L) |
NOELR* |
NOELR# |
EL10 |
ECL20 |
EL50 |
|
Growth rate |
Value |
<1.0 |
3.2 |
5.9 |
7.6 |
12.4 |
lower 95%-cl |
|
|
5.3 |
7.1 |
11.8 |
|
upper 95%-cl |
|
|
6.6 |
8.2 |
13.2 |
|
Yield |
Value |
<1.0 |
<1.0 |
2.5 |
3.3 |
5.5 |
lower 95%-cl |
|
|
2.2 |
3.0 |
5.1 |
|
upper 95%-cl |
|
|
2.8 |
3.6 |
5.9 |
cl – confidence limit, *) - based on statistical significance, #)- based on biological relevance.
Details on Analytical Data:
At this time, analytical data are available for the range-finding test, only. Data on the final test will be amended as soon as they will become available.
1) Analysis of the relevant transition metal by ICP-MS
Time of sampling hours |
Date of sampling |
Date of analysis |
Loading rate (WAF) [mg/L] |
Concentration test item analysed [mg/L] |
Relative to initial [%] |
Transition metal concentration calculated from elemental fraction (0.8%) determined in study number 519586 [mg/L] |
0 |
15 Oct 2018 |
24 Oct 2018 |
1 |
0.37 |
0.003 |
|
|
|
|
100 |
23.1 |
|
0.185 |
24 |
16 Oct 2018 |
24 Oct 2018 |
1 |
0.34 |
92 |
0.003 |
|
|
|
100 |
23.2 |
100 |
0.186 |
72 |
18 Oct 2018 |
24 Oct 2018 |
1 |
0.34 |
92 |
0.003 |
|
|
|
100 |
23.7 |
103 |
0.190 |
2) Analysis of the organics fraction by LC-UV at 210 nm
Time of sampling [hours] |
Date of sampling |
Date ofanalysis |
Loading rate WAF [mg/L] |
Concentration analysed [mg/L] |
Relative to initial [%] |
0 |
15 Oct 2018 |
31 Oct 2018 |
1.0 |
1.86 |
|
|
|
|
100 |
221 |
|
24 |
17 Oct 2018 |
31 Oct 2018 |
1.0 |
0.755 |
41 |
|
|
|
100 |
15.8 |
7.1 |
72 |
15 Oct 2018 |
31 Oct 2018 |
1.0 |
0.049 |
2.7 |
|
|
|
100 |
0.44 |
0.20 |
Description of key information
The toxicity to freshwater green algae was tested according to OECD 201 compliant with GLP. Due to the nature of Step 2 catalyst (UVCB), according to OECD 23 water accommodated fractions (WAF) were prepared.
Results:
NOELR (Pseudokirchneriella subcapitata; 72 h; static; growth rate) = 3.2 mg/L;
EL10 (Pseudokirchneriella subcapitata; 72 h; static; growth rate) = 5.9 mg/L (95% CI: 5.3-6.6)
EL50 (Pseudokirchneriella subcapitata; 72 h; static; growth rate) = 12.4 mg/L (95% CI: 11.8-13.2)
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 12.4 mg/L
- EC10 or NOEC for freshwater algae:
- 5.9 mg/L
Additional information
The toxicity to freshwater green algae was tested according to OECD 201 compliant with GLP. The test organism was Pseudokirchneriella subcapitata. Due to the nature of Step 2 catalyst (UVCB), according to OECD 23 water accommodated fractions (WAF) were prepared and based on the results of a range finding tests (significant effects observed at WAF 10 and 100 mg/L) the final test was conducted at WAFs were prepared at 1.0, 3.2, 10, 32 and 100 mg/L nominal loading: individual loading rates were vigorously agitated on a magnetic stirrer for 6 days. Based on preliminary results, the period of 6 days of stirring was used to ensure that
a) Concentration of the relevant transition metal stabilizes at the pH 8.0 ± 0.3 used for ecotoxicity testing to prevent any precipitation during the test;
b) Saturation of the aquatic phase with organic hydrolysis products stemming from aromatic phosphites is obtained.
The presence of any non-dissolved test item fraction could be excluded before testing by measuring the Tyndall effect.
Analytical monitoring was performed for the relevant transition metal (ICP-MS) as well as the organic fraction (UPLC-UV at 210 nm). At WAF 1 mg/L and 100 mg/L transition metal concentration was stable over the 72 hours of the test. Step 2 catalyst concentration equivalent of 0.37 and 23.1 mg/L, respectively, was found in freshly prepared WAF (after 6 days of stirring and one day settling period). For WAF 1 mg/L, 92% of this initial concentration was recovered after 24 and 72 hours (0.34 mg/L). For WAF 100 mg/L, 100% and 103% of the initial concentration was recovered after 24 and 72 hours (23.2 / 23.7 mg/L). This is equivalent to transition metal concentrations of ca. 3 µg/L for WAF 1 mg/L and ca. 190 µg/L for WAF 100 mg/L.
With regard to the organics fraction monitored via UPLC-UV at 210 nm, initial Step 2 catalyst concentration equivalents of 1.86 mg/L and 221 mg/L were measured for WAF 1 and WAF 100 mg/L, respectively. Over the time course of the study (72 h) there was a relevant decline to 2.7 % of initial for WAF 1 mg/L and 0.2% of initial for WAF 100 mg/L. The reason for this decline is not clear. In the corresponding test for acute toxicity on Daphnia and fish an increase of absorption at 210 nm was observed. The decrease over time observed here could be either due to adsorption to algal biomass and/or further abiotic transformations (hydrolysis / oxidation) to molecular species with different chromatographic elution time / different absorption maxima during the test. The results confirm in any case that WAF preparation succeeded in a relevant organic fraction present at least at the beginning of the test.
The following results were obtained in the final test (based on growth rate inhibition):
NOELR (Pseudokirchneriella subcapitata; 72 h; static; growth rate) = 3.2 mg/L;
EL10 (Pseudokirchneriella subcapitata; 72 h; static; growth rate) = 5.9 mg/L (95% CI: 5.3-6.6)
EL50 (Pseudokirchneriella subcapitata; 72 h; static; growth rate) = 12.4 mg/L (95% CI: 11.8-13.2)
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