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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:
- From 2018-01-07 to 2018-01-11, with the definitive exposure phase from 2018-01-08 to 2018-01-11
- 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
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Remarks:
- TOC Analysis
- Vehicle:
- no
- Details on test solutions:
- Water Accommodated Fraction
Water accommodated fractions (WAF) were prepared because the test item is an UVCB substance with compounds of different water solubility. This procedure is in accordance with the OECD guidance document No. 23 (2018) Using this approach, aqueous media were prepared by mixing the test item with water for a prolonged period sufficient to ensure equilibration between the test item and the water phase.
Preparation of the WAF
One water accommodated fraction (WAF) was prepared with a nominal loading rate of 100 mg test item/L.
For the loading rate, an appropriate amount of the test item was weighed out. The test item was applied onto a glass slide. The glass slide with the test item was inserted into a brown glass flask with an appropriate amount of dilution water. This dispersion was shaken for at least 24 hours with 20 rpm at room temperature. After a separation phase of 1 hour, the aqueous phase or WAF was removed by siphoning (from the approximate centre of the glass flask). The resulting water accommodated fraction (WAF) was used in the test.
Test loading
Per definition of the WAF all terms related to concentration level are given as loading rates because partly dissolved compounds and mixtures cannot be related to concentrations.
The loading rates are based on the results of a preliminary range finding test (non-GLP, open system with headspace).
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
- Common name: Pseudokirchneriella subcapitata HINDÁK, CCAP 278/4
- Strain: CCAP 278/4
- Source (laboratory, culture collection):
Culture Collection of Algae and Protozoa (CCAP)
SAMS Research Services Ltd
Dunstaffnage Marine Laboratory
Dunbeg, OBAN; Argyll PA37 1QA; Scotland, UK
- Age of inoculum (at test initiation): 4 days
- Method of cultivation: Fresh stocks were prepared every month on Z-Agar. Light intensity amounted to 2567 – 5130 lux corresponding to 35 - 70 µE ∙ m-2 ∙ s-1 for 24 h per day. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Post exposure observation period:
- No
- Hardness:
- Not specified
- Test temperature:
- min.: 21.0 max.: 22.5 mean value: 21.8
- pH:
- Nominal test item loading pH-values
[mg/L] Start; 0 hours End; 72 hours
100 8.03 8.88
Control 8.08 9.07 - Dissolved oxygen:
- Not measured
- Salinity:
- Not measured, freshwater conditions
- 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 10^3 cells/mL, Actual: mean 6442 cells/mL
- Control end cells density: Mean 1532094 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:
Ultrapure water was used to prepare the dilution water (conductivity max. 0.1 µS/cm)
Composition of Dilution Water
according to the guideline
Component Concentration [mg/L]
NH4Cl 15
MgCl2 x 6 H2O 12
CaCl2 x 2 H2O 18
MgSO4 x 7 H2O 15
KH2PO4 1.6
FeCl3 x 6 H2O 0.064a2EDTA x 2 H2O 0.1
H3BO3 0.185
MnCl2 x 4 H2O 0.415
ZnCl2 3 x 10^-3
Na2MoO4 x 2 H2O 7 x 10^-3
CoCl2 x 6 H2O 1.5 x 10^-3
CuCl2 x 2 H2O 1 x 10^-5
NaHCO3 50
pH 8.1 ± 0.2
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod: 24 h
- Light intensity and quality: Approximately 4440 to 8880 lux, corresponding to 60 to 120
µE ∙ m-2 ∙ s-1, mean value: 6003 lux,measured: 5223 - 6709 with a mean of 6033 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
-Chlorophyll a-fluorescence
The cell density was measured daily via Chlorophyll a-fluorescence, excitation at 436 nm, emission at 685 nm. Dilution water was used as a background signal. No self-fluorescence was found in the preliminary range finding test at the loading rate of 100 mg/L. - Reference substance (positive control):
- yes
- Remarks:
- (Potassium dichromate)
- Duration:
- 72 h
- Dose descriptor:
- other: NOEL
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: growth rate und yield inhibition
- Duration:
- 72 h
- Dose descriptor:
- other: LOEL
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: growth rate and yield inhibition
- Duration:
- 72 h
- Dose descriptor:
- other: EL10/20/50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: growth rate and yield
- 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: The test solutions were clear and colourless during the exposure period.
- Effect concentrations exceeding solubility of substance in test medium: No - 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 2018-09-25 to 2018-09-28. The reference item toxicity is in the valid range which was established by calculation of the average of the historic reference data since 2005, and the limits were set using the threefold standard deviation of these values.
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 0.799 0.753 ± 0.544
95% confidence interval 0.707 – 1.30
Yield inhibition
EyC50 0.607 0.407 ± 0.313
95% confidence interval 0.404 – 0.694
SD = Standard deviation - Reported statistics and error estimates:
- EL-values and statistical analyses
EL-values of the growth rate and yield inhibition were estimated empirically based on the results of the single treatment level (Limit test design).
NOEL and LOEL values
NOEL/LOEL were determined by calculation of statistical significance of growth rate and yield. As a standard, a t-test was used for NOEL/LOEL calculations. When running a t-test a Normality test and an Equal Variance test were done first. The SHAPIRO-WILK-Test was used to test for normal distribution of data. The Brown-Forsythe test was done for analysis of variance homogeneity. 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 are 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. - Validity criteria fulfilled:
- yes
- Conclusions:
- In this study, Licocare RBW 300 was found not to inhibit the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours.
Effect values were determined as follows (based on nominal test item loadings):
The EL50-values for both inhibition of growth rate (ErL50) and yield (EyL50) after 72 hours were > 100 mg/L. The NOEL-values for both inhibition of growth rate and yield after 72 hours were 100 mg/L. - Executive summary:
The toxicity of Licocare RBW 300 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 from 2018-01-07 to 2018-01-11, with the definitive exposure phase from 2018-01-08 to 2018-01-11 at the test facility. The aim of the study was the determination of NOEL, LOEL, EL10, EL20- and EL50-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 6442 cells/mL. As the test item is a UVCB substance, a water accommodated fraction (WAF) with the nominal loading rate of 100 mg test item/L was prepared.
Six replicates were tested for the limit loading and six for the control. The test media were clear and colorless throughout the test period. The environmental conditions were within the acceptable limits.
Due to the low solubility of the test item, no analytical monitoring was carried out.
All effect values given are based on the nominal test item loading of Licocare RBW 300.
NOEL, LOEL, ELx-values ofLicocareRBW 300(0 - 72 hours)
based on the nominal test item loadings
Growth Rate Inhibition
nominal test item loadings [mg/L]NOEL
100
LOEL
> 100
ErL10
> 100
ErL20
> 100
ErL50
> 100
Yield Inhibition
nominal test item loadings [mg/L]
NOEL
100
LOEL
> 100
EyL10
> 100
EyL20
> 100
EyL50
> 100
Reference
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 loadings.
Cell Densities
Nominal test item loading |
Replicate |
Cell density [cells/mL] |
|||||||||
[mg/L] |
No. |
0 hours |
24 hours |
48 hours |
72 hours |
||||||
100 |
1 |
6442 |
21498 |
160029 |
1415350 |
||||||
2 |
6442 |
23343 |
182114 |
1476966 |
|||||||
3 |
6442 |
22345 |
179442 |
1469618 |
|||||||
4 |
6442 |
24567 |
170754 |
1604963 |
|||||||
5 |
6442 |
24656 |
186135 |
1509536 |
|||||||
6 |
6442 |
18989 |
172829 |
1422202 |
|||||||
Mean |
6442 |
22566 |
175217 |
1483106 |
|||||||
Control |
1 |
6442 |
24808 |
176682 |
1633562 |
||||||
2 |
6442 |
24520 |
198568 |
1512614 |
|||||||
3 |
6442 |
23132 |
196373 |
1491613 |
|||||||
4 |
6442 |
22665 |
194536 |
1547767 |
|||||||
5 |
6442 |
20637 |
197028 |
1455219 |
|||||||
6 |
6442 |
22514 |
210643 |
1551788 |
|||||||
Mean |
6442 |
23046 |
195638 |
1532094 |
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 loading |
Replicate |
Growth rate |
Growth rate inhibition |
Yield |
Inhibition of yield |
||
[mg/L] |
No. |
[d-1] |
[%] |
[cells/mL] |
[%] |
||
100 |
1 |
|
1.80 |
1 |
|
1408908 |
8 |
2 |
|
1.81 |
1 |
|
1470524 |
4 |
|
3 |
|
1.81 |
1 |
|
1463176 |
4 |
|
4 |
|
1.84 |
-1 |
|
1598521 |
-5 |
|
5 |
|
1.82 |
0 |
|
1503094 |
1 |
|
6 |
|
1.80 |
1 |
|
1415760 |
7 |
|
Mean |
(-) |
1.81 |
1 |
(-) |
1476664 |
3 |
|
Control |
1 |
|
1.85 |
|
|
1627120 |
|
2 |
|
1.82 |
|
|
1506172 |
|
|
3 |
|
1.82 |
|
|
1485171 |
|
|
4 |
|
1.83 |
|
|
1541325 |
|
|
5 |
|
1.81 |
|
|
1448777 |
|
|
6 |
|
1.83 |
|
|
1545346 |
|
|
Mean |
|
1.82 |
|
|
1525652 |
|
Section-by-Section and Average Specific Growth Ratesof the Control Group (0 - 72 hours)
|
Replicate No. |
Specific growth rate [d-1] |
Mean (0 - 72 hours) |
SD ± |
CV |
Mean CV [%] |
||
section-by-section |
||||||||
0 - 24 hours |
24 - 48 hours |
48 - 72 hours |
||||||
Control |
1 |
1.35 |
1.96 |
2.22 |
1.85 |
0.450 |
24.4 |
26.7 |
2 |
1.34 |
2.09 |
2.03 |
1.82 |
0.419 |
23.0 |
||
3 |
1.28 |
2.14 |
2.03 |
1.82 |
0.468 |
25.8 |
||
4 |
1.26 |
2.15 |
2.07 |
1.83 |
0.495 |
27.1 |
||
5 |
1.16 |
2.26 |
2.00 |
1.81 |
0.571 |
31.6 |
||
6 |
1.25 |
2.24 |
2.00 |
1.83 |
0.514 |
28.1 |
||
|
|
|
Mean |
1.82 |
|
|
||
|
|
|
SD ± |
0.01 |
|
|||
|
|
|
CV [%] |
0.73 |
|
SD = Standard deviation CV = Coefficient of variation
Description of key information
The toxicity ofLicocare RBW 300 to the unicellular freshwater green algaPseudokirchneriella subcapitatawas determined according to the principles of OECD 201 andCouncil Regulation (EC) No. 266/2016/Method C.3
In this study, Licocare RBW 300 was found not to inhibit the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours.
Effect values were determined as follows (based on nominal test item loadings):
The EL50-values for both inhibition of growth rate (ErL50) and yield (EyL50) after 72 hours were > 100 mg/L. The NOEL-values for both inhibition of growth rate and yield after 72 hours were 100 mg/L.
Key value for chemical safety assessment
- EC10 or NOEC for freshwater algae:
- 100 mg/L
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.