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EC number: 947-922-8 | 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 2018-05-25 to 2018-05-31, with the definitive exposure phase from 2018-05-28 to 2018-05-31 at the test facility.
- 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
- Specific details on test material used for the study:
- Test item N-(Oleyl alkyl)- 1,3-propanediamine mono oleate (100%)
CAS no 40027-38-1
Batch no. P15-005
Purity (certified) 99.62% (100% - water content)
0.38% (water content)
Water solubility 80 mg/L (CMC acc. to OECD 115)
Appearance Beige molten (paste-like)
Stability under test not specified
conditions
Best before date 2020-02-18
Recommended storage Keep container tightly closed in a dry and well ventilated place. Avoid elevated temperatures. - Analytical monitoring:
- yes
- Details on sampling:
- Determination of the test item
All concentration levels and the control were analytically verified via LC-MS/MS after 0 (start of exposure) and 72 hours (end of the exposure) with algae.
The samples were analysed with an LC-MS/MS method, implemented under non-GLP and documented in the GLP raw data. The method was validated.
Sampling for the analytical monitoring
At the start of the exposure (0 hours), samples of the fresh media were taken after preparation of the test concentrations and analyzed.
At the end of the exposure (72 hours), samples of the old media were taken from the test vessels for analysis. - Vehicle:
- no
- Details on test solutions:
- Preparation of the saturated solutions
A stock solution with an nominal loading of 100 mg/L was prepared with dilution water as specified in Table 2 three days before the start of the exposure. A glass bottle was filled with an appropriate amount of the dilution water, an appropriate volume of the test item (density: 0.98 g/cm³ (20 °C) was taken into account) was placed by pipette onto the water surface and the bottle was closed with the screw cap. A slow stirring procedure was applied. Gentle stirring (to avoid formation of an emulsion) was carried out for 72 hours with a magnetic stirrer at room temperature. Undissolved particles were removed by membrane filtration (membrane filter 0.45 µm, RC, MACHEREY-NAGEL). The filter was saturated in order to avoid adsorption during the filtration. The first 25 mL of the filtrate were discarded. The filtration was interrupted for 15 minutes to allow adsorption and saturation of the filter material with dissolved test item. Thereafter, the filtration was continued. The next 25 mL were discarded. The following solution was used as the highest concentration in the test and for preparation the dilution levels. During filtration, the filter was always be kept covered. The solution was checked via laser beam (Tyndall effect) for undissolved test item.
Test concentrations
Five concentrations in a geometric series with a factor of √10, prepared by dilution of the stock solution 100 mg/L with dilution water, were tested as
follows: 1.00 – 3.16 – 10.0 – 31.62 – 100 % of the saturated solution.
The dilution levels are based on the results of a preliminary range finding test (non-GLP).
Control Six replicates (without test item) were tested under the same test conditions as the test item replicates. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata HINDÁK
- Strain: CCAP
- 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): 3 days
- Method of cultivation: Fresh stocks were prepared every month on Z-Agar. Light intensity amounted to 2590 – 5180 lux corresponding to 35 - 70 µE ∙ m-2 ∙ s-1 for 24 h per day. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- No
- Hardness:
- Not specified
- Test temperature:
- min.: 22.0 max.: 23.0 mean value: 22.5
- pH:
- Calculated test item concentration pH-values
[mg/L] Start; 0 hours End; 72 hours
2.89 7.41 7.53
0.913 7.51 7.73
0.289 7.57 8.00
0.0913 7.68 8.03
0.0289 7.70 8.34
Control 8.15 8.47 - 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 1558142 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:
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: 5244 - 6535 with a mean of 5560 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 definitive test in the saturated solution. - Reference substance (positive control):
- yes
- Remarks:
- (Potassium dichromate)
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.289 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- other: growth rate und yield inhibition
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.913 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- other: growth rate and yield inhibition
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.871 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: CI: (0.455 - 2.40)
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- 1.17 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: CI: (0.974 - 2.47)
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.9 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: CI: (1.23 - 2.68)
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.469 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield inhibition
- Remarks on result:
- other: CI (0.341 - 0.600)
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- 0.593 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield inhibition
- Remarks on result:
- other: CI (0.456 - 0.700)
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.963 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield inhibition
- Remarks on result:
- other: CI: (0.870 - 1.11)
- 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 media were clear throughout the exposure phase.
- 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 2018-03-26 to 2018-03-29. The reference item toxicity is in the valid range following test facility SOPS.
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 1.09 0.759 ± 0.555
95% confidence interval 0.842 – 1.31
Yield inhibition
EyC50 0.548 0.401 ± 0.297
95% confidence interval 0.439 – 0.660
SD = Standard deviation - Reported statistics and error estimates:
- Calculation of the test item Concentrations
For calculation of the test item concentrations, the geometric mean measured concentration of the stock solution was determined. The other concentration levels were calculated based on this geometric mean measured stock solution concentration with the dilution factor (√10). This procedure was carried out, because the measured concentrations of the three lowest concentration levels were below the LOQ and all concentration levels were diluted from the same stock solution.
EC-values and statistical analyses
EC10-, EC20- and EC50-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 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 -value (acceptable probability of incorrectly concluding that there is a difference) is =0.05. As the Normality Test failed for growth rate, the data was square-transformed for analysis.
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, the effect values of Reaction products of alcohols, C11-14-iso,C13 rich and phosphorus pentoxide on the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours were determined as follows (based on calculated test item concentrations):
The EC50-values for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were 1.90 (1.23 – 2.68) mg/L and 0.963 (0.870 – 1.11) mg/L, respectively. The NOEC for both growth rate and yield was 0.289 mg/L, respectively. - Executive summary:
The toxicity of Reaction productsof alcohols, C11-14-iso,C13 rich and phosphorus pentoxide o 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 2018-05-25 to2018-05-31, with the definitive exposure phase from 2018-05-28 to 2018-05-31 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.Five concentrations were tested in a geometrical series with factor of√10 in the concentration range of 1.00 - 3.16 - 10.0 - 31.6 - 100% of the saturated solution. A saturated solution was prepared and slowly stirred for 72 hours. The solution was then filtrated and used for the preparation of the dilution solutions.
Three replicates were tested for each test item concentration and six replicates for the control. The environmental conditions were within the acceptable limits. The measured concentrations in the three highest test solutions at the start of the exposure were 2.89 mg/L, 0.766 mg/L and 0.186 mg/L. All other test item solutions were < LOQ. At the end of exposure after 72 hours, the measured concentrations in the two highest concentrations were 104 and 88% of the initially measured test item concentrations, all other measurements were < LOQ. As the concentrations remained in the nominal range of the initially measured concentrations, all solutions were prepared from the saturated solution and the dilution factor was reflected in the measured concentrations, the exposure concentrations were calculated from the value for the saturated solution.
All effect values given are based on the calculated test item concentrations of Reaction products of alcohols, C11-14-iso,C13 rich and phosphorus pentoxide.
NOEC, LOEC, ECx-values ofReactionproductsof alcohols, C11-14-iso,C13 rich and phosphorus pentoxide(0 - 72 hours)
(based on the calculated test item concentrations, with 95% confidence intervals)
Growth Rate Inhibition
calculated test item concentrations, with 95% confidence intervals [mg/L]NOEC
0.289
LOEC
0.913
ErC10
0.871 (0.455 – 2.40)
ErC20
1.17 (0.974 – 2.47)
ErC50
1.90 (1.23 – 2.68)
Yield Inhibition
calculated test item concentrations, with 95% confidence intervals [mg/L]
NOEC
0.289
LOEC
0.913
EyC10
0.469 (0.341 – 0.600)
EyC20
0.593 (0.456 – 0.700)
EyC50
0.963 (0.870 – 1.11)
Reference
Cell Densities
Calculated test item concentration |
Replicate |
Cell density [cells/mL] |
|||||||||
[mg/L] |
No. |
0 hours |
24 hours |
48 hours |
72 hours |
||||||
2.89 |
1 |
6442 |
9140 |
11035 |
10133 |
||||||
2 |
6442 |
10287 |
14637 |
23604 |
|||||||
3 |
6442 |
11094 |
10665 |
11454 |
|||||||
Mean |
6442 |
10174 |
12112 |
15064 |
|||||||
0.913 |
1 |
6442 |
26019 |
125528 |
842603 |
||||||
2 |
6442 |
26041 |
151673 |
805762 |
|||||||
3 |
6442 |
19577 |
131525 |
869016 |
|||||||
Mean |
6442 |
23879 |
136242 |
839127 |
|||||||
0.289 |
1 |
6442 |
31309 |
218482 |
1644549 |
||||||
2 |
6442 |
31265 |
204352 |
1668133 |
|||||||
3 |
6442 |
25302 |
185594 |
1408414 |
|||||||
Mean |
6442 |
29292 |
202809 |
1573699 |
|||||||
0.0913 |
1 |
6442 |
32096 |
244856 |
1634123 |
||||||
2 |
6442 |
31875 |
214560 |
1660288 |
|||||||
3 |
6442 |
32310 |
141217 |
1824680 |
|||||||
Mean |
6442 |
32094 |
200211 |
1706364 |
|||||||
0.0289 |
1 |
6442 |
27717 |
225910 |
1604482 |
||||||
2 |
6442 |
31714 |
204898 |
1598921 |
|||||||
3 |
6442 |
33136 |
236575 |
1711130 |
|||||||
Mean |
6442 |
30856 |
222461 |
1638178 |
|||||||
Control |
1 |
6442 |
32056 |
256186 |
1722649 |
||||||
2 |
6442 |
32590 |
248868 |
1626775 |
|||||||
3 |
6442 |
26195 |
207281 |
1517148 |
|||||||
4 |
6442 |
31361 |
191185 |
1308419 |
|||||||
5 |
6442 |
32876 |
251460 |
1509402 |
|||||||
6 |
6442 |
31649 |
273544 |
1664459 |
|||||||
Mean |
6442 |
31121 |
238087 |
1558142 |
Evaluation after 72 hours
Statistically
significant differences of growth rates and yield compared to
control
values are marked (+), not significant differences are marked (-).
Calculated test item concentration |
Replicate |
Growth Rate |
Inhibition of Growth Rate |
Yield |
Inhibition of Yield |
||
[mg/L] |
No. |
[d-1] |
[%] |
[cells/mL] |
[%] |
||
2.89 |
1 |
|
0.15 |
92 |
|
3691 |
100 |
2 |
|
0.43 |
76 |
|
17162 |
99 |
|
3 |
|
0.19 |
90 |
|
5012 |
100 |
|
Mean |
(+) |
0.26 |
86 |
(+) |
8622 |
99 |
|
0.913 |
1 |
|
1.63 |
11 |
|
836161 |
46 |
2 |
|
1.61 |
12 |
|
799320 |
48 |
|
3 |
|
1.64 |
11 |
|
862574 |
44 |
|
Mean |
(+) |
1.62 |
11 |
(+) |
832685 |
46 |
|
0.289 |
1 |
|
1.85 |
-1 |
|
1638107 |
-6 |
2 |
|
1.85 |
-1 |
|
1661691 |
-7 |
|
3 |
|
1.80 |
2 |
|
1401972 |
10 |
|
Mean |
(-) |
1.83 |
0 |
(-) |
1567257 |
-1 |
|
0.0913 |
1 |
|
1.85 |
-1 |
|
1627681 |
-5 |
2 |
|
1.85 |
-1 |
|
1653846 |
-7 |
|
3 |
|
1.88 |
-3 |
|
1818238 |
-17 |
|
Mean |
(-) |
1.86 |
-2 |
(-) |
1699922 |
-10 |
|
0.0289 |
1 |
|
1.84 |
-1 |
|
1598040 |
-3 |
2 |
|
1.84 |
-1 |
|
1592479 |
-3 |
|
3 |
|
1.86 |
-2 |
|
1704688 |
-10 |
|
Mean |
(-) |
1.85 |
-1 |
(-) |
1631736 |
-5 |
|
Control |
1 |
|
1.86 |
|
1716207 |
||
2 |
|
1.84 |
|
1620333 |
|||
3 |
|
1.82 |
|
1510706 |
|||
4 |
|
1.77 |
|
1301977 |
|||
5 |
|
1.82 |
|
1502960 |
|||
6 |
|
1.85 |
|
1658017 |
|||
Mean |
|
1.83 |
|
1551700 |
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 |
1.61 |
2.08 |
1.91 |
1.86 |
0.240 |
12.9 |
13.4 |
2 |
1.62 |
2.03 |
1.88 |
1.84 |
0.208 |
11.3 |
||
3 |
1.40 |
2.07 |
1.99 |
1.82 |
0.364 |
20.0 |
||
4 |
1.58 |
1.81 |
1.92 |
1.77 |
0.173 |
9.78 |
||
5 |
1.63 |
2.04 |
1.79 |
1.82 |
0.204 |
11.2 |
||
6 |
1.59 |
2.16 |
1.81 |
1.85 |
0.285 |
15.4 |
||
|
|
|
Mean |
1.83 |
|
|
||
|
|
|
SD ± |
0.03 |
|
|||
|
|
|
CV [%] |
1.79 |
|
SD = Standard deviation CV = Coefficient of variation
Description of key information
In this study, the effect values of Reaction products of alcohols, C11-14-iso,C13 rich and phosphorus pentoxide on the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours were determined as follows (based on calculated test item concentrations):
The EC50-values for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were 1.90 (1.23 – 2.68) mg/L and 0.963 (0.870 – 1.11) mg/L, respectively. The NOEC for both growth rate and yield was 0.289 mg/L, respectively.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 1.9 mg/L
- EC10 or NOEC for freshwater algae:
- 0.8 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.