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EC number: 231-609-1 | CAS number: 7651-02-7
- 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
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-02-04 to 2013-02-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]stearamide
- EC Number:
- 231-609-1
- EC Name:
- N-[3-(dimethylamino)propyl]stearamide
- Cas Number:
- 7651-02-7
- Molecular formula:
- C23H48N2O
- IUPAC Name:
- N-[3-(dimethylamino)propyl]octadecanamide
- Test material form:
- solid: pellets
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 10.0 - 31.6 - 100 - 316 - 1000 µg/L
- Sampling method: All test item concentrations and the control were analytically verified via LC-MS/MS at the beginning and end of the test. Samples at test start were taken from an additional replicate without algae. At end of the test samples were taken directly from the pooled test replicates.
- Sample storage conditions before analysis:All samples were stored at room temperature. Prepared samples were stored at room temperature until analysis.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution of 100 mg/L was freshly prepared with demineralised water. The pH-value of the demineralised water was adjusted to pH 2 ± 0.1 by adding 1 M HCl. The test item dispersion was stirred with a magnetic stirrer for 18.5 hours. The test concentrations were prepared from this stock solution by dilution with natural river water without further adjustment of the pH-value.
- Eluate: Water of the river Innerste was used. The river water was supplemented with 50 % of the OECD medium to enable a sufficient growth of the algae (total application volume 6.5 mL/L).
River Innerste
Location Amtshof K514, km 26,
31157 Ruthe-Sarstedt, Germany
Latitude:52.25°, Longitude: 9.83°
Sampling Date 2012-09-17
Weather on Day of Sampling Sunny, slightly clouded; approx. 18 °C
Colour Yellowish to brownish, clear
pH 7.56
Conductivity [µS/cm] 898
Dissolved Oxygen [mg O2/L] 8.83
NPOC [mg C/L] 3.13
Ammonium-N [mg N/L] 0.05
Nitrate-N [mg N/L] 1.70
Total Nitrogen [mg N/L] 2.70
o-Phosphate-p [mg P/L] < 0.20
Total Phosphate [mg P/L] < 0.20
Suspended Matter [mg/L] 16.4
Total Hardness [mg CO3/L] 283
Storage conditions 15 ± 2°C
The natural river water was stored at 15 ± 2 °C and at - 18 2 °C for at least 24 hours. Freezing was found to be suitable to minimize the content of vital natural algae cells of the water as well as to reduce microbial (bacterial) activity.
Composition of Dilution Water
Component Concentration [mg/L]
NH4Cl 15
MgCl2 6 H2O 12
CaCl2 2 H2O 18
MgSO4 7 H2O 15
KH2PO4 1.6
FeCl3 6 H2O 0.064
Na2EDTA 2 H2O 0.1
H3BO3 0.185
MnCl2 4 H2O 0.415
ZnCl2 3 x 10-3
Na2MoO4 2 H2O 7 x 10-3
CoCl2 6 H2O 1.5 x 10-3
CuCl2 2 H2O 1 x 10-5
NaHCO3 50
pH 8.1 0.2
- Differential loading: 10.0 - 31.6 - 100 - 316 - 1000 µg/L
- Controls: Six replicates (without test item) were tested under the same test conditions as the test replicates.
Test organisms
- Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Common name: Desmodesmus subspicatus Chodat
- Strain: SAG 86.81
- Source (laboratory, culture collection): SAG Pflanzenphysiologisches Institut der Universitaet Goettingen, Nikolausberger Weg 18, D-37073 Goettingen, Germany
- Age of inoculum (at test initiation): 4 days
- Method of cultivation: Fresh stocks were prepared every month on Z-Agar. Light intensity amounted to 35 - 70 µE x m-2 x s-1 for 24 h per day.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- No
Test conditions
- Test temperature:
- min.: 21.0 max.: 22.5, mean value: 21.8 °C
- pH:
- Nominal concentration pH-value
Test item
[µg/L] Start; 0 hours End; 72 hours
1000 8.05 8.30
316 8.06 8.43
100 8.06 8.50
31.6 8.06 8.53
10.0 8.05 8.53
Control 8.04 8.54 - Dissolved oxygen:
- Not measured
- Salinity:
- Not measured, freshwater conditions
- Nominal and measured concentrations:
- See window "Any other information on materials and methods incl. tables"
- 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 4332 cells/mL
- Control end cells density: Mean 687640 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 6 H2O 12
CaCl2 2 H2O 18
MgSO4 7 H2O 15
KH2PO4 1.6
FeCl3 6 H2O 0.064
Na2EDTA 2 H2O 0.1
H3BO3 0.185
MnCl2 4 H2O 0.415
ZnCl2 3 x 10-3
Na2MoO4 2 H2O 7 x 10-3
CoCl2 6 H2O 1.5 x 10-3
CuCl2 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: 60 - 120 µE x m-2 x s-1, mean value: 73.2
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
Results of the Range Finding Test (0-72 hours)
Nominal Test Item Concentration
[mg/L] Growth Rate Inhibition [%] Yield Inhibition [%]
10.0 100 100
1.00 100 100
0.100 14 39
0.0100 -5 -17
- Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 140 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI 321-427 µg/L
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 71 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI 63-79 µg/L
- 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
Actual Study Valid Range (average ± 3 x SD)
Growth Rate Inhibition
ErC50 0.631 0.682 ± 0.452
95 %
confidence
interval 0.583 - 0.687
Yield Inhibition
EyC50 0.256 0.314 ± 0.144
95 %
confidence
interval 0.247 - 0.265
SD = Standard deviation - Reported statistics and error estimates:
- NOEC/LOEC were determined by calculation of statistical significance of growth rate and yield. As 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. The SHAPIRO-WILK-Test was used to test for normally distributed populations. The Levene median test was used for equal variance. 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. For growth rate the data were transformed (y = 10y) to achieve normally distributed data.
Any other information on results incl. tables
Cell Densities
|
Nominal test item concentration |
Replicate |
Cell density [cells/mL] |
||||||
[µg/L] |
No. |
0 hours |
24 hours |
48 hours |
72 hours |
|
|||
1000 |
1 |
4332 |
2844 |
3344 |
|
||||
2 |
4332 |
3992 |
|
||||||
3 |
4332 |
3180 |
|
||||||
Mean |
4332 |
n.a. |
n.a. |
3505 |
|
||||
316 |
1 |
4332 |
2608 |
5464 |
|
||||
2 |
4332 |
3995 |
6391 |
|
|||||
3 |
4332 |
2567 |
8477 |
|
|||||
Mean |
4332 |
3057 |
n.a. |
6777 |
|
||||
100 |
1 |
4332 |
10879 |
24544 |
173608 |
|
|||
2 |
4332 |
9294 |
27998 |
237499 |
|
||||
3 |
4332 |
5671 |
18431 |
144155 |
|
||||
Mean |
4332 |
8615 |
23658 |
185087 |
|
||||
31.6 |
1 |
4332 |
16349 |
108802 |
780958 |
|
|||
2 |
4332 |
17761 |
128716 |
808005 |
|
||||
3 |
4332 |
14861 |
126798 |
840933 |
|
||||
Mean |
4332 |
16324 |
121439 |
809965 |
|
||||
10.0 |
1 |
4332 |
14078 |
113174 |
753345 |
|
|||
2 |
4332 |
11933 |
103456 |
738060 |
|
||||
3 |
4332 |
13084 |
101455 |
658775 |
|
||||
Mean |
4332 |
13032 |
106028 |
716727 |
|
||||
Control |
1 |
4332 |
14968 |
108022 |
695099 |
|
|||
2 |
4332 |
16518 |
106827 |
658837 |
|
||||
3 |
4332 |
18220 |
111507 |
747306 |
|
||||
4 |
4332 |
14575 |
98065 |
637514 |
|
||||
5 |
4332 |
13531 |
100965 |
742180 |
|
||||
6 |
4332 |
13257 |
91322 |
644905 |
|
||||
Mean |
4332 |
15178 |
102785 |
687640 |
|
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 |
Growth rate inhibition |
Yield |
Inhibition of yield |
||
[µg/L] |
No. |
[d-1] |
[%] |
[cells/mL] |
[%] |
||
1000 |
1 |
-0.086 |
100 |
-988 |
100 |
||
2 |
-0.027 |
100 |
-340 |
100 |
|||
3 |
-0.103 |
100 |
-1152 |
100 |
|||
Mean |
(+) |
-0.0722 |
100 |
(+) |
-827 |
100 |
|
316 |
1 |
0.077 |
95.4 |
1132 |
99.8 |
||
2 |
0.130 |
92.3 |
2059 |
99.7 |
|||
3 |
0.224 |
86.8 |
4145 |
99.4 |
|||
Mean |
(+) |
0.144 |
91.5 |
(+) |
2445 |
99.6 |
|
100 |
1 |
1.23 |
27.1 |
169276 |
75.2 |
||
2 |
1.34 |
21.0 |
233167 |
65.9 |
|||
3 |
1.17 |
30.8 |
139823 |
79.5 |
|||
Mean |
(+) |
1.24 |
26.3 |
(+) |
180755 |
73.6 |
|
31.6 |
1 |
1.73 |
-2.55 |
776626 |
-13.7 |
||
2 |
1.74 |
-3.23 |
803673 |
-17.6 |
|||
3 |
1.76 |
-4.01 |
836601 |
-22.4 |
|||
Mean |
(+)# |
1.74 |
-3.26 |
(+)# |
805633 |
-17.9 |
|
10.0 |
1 |
1.72 |
-1.84 |
749013 |
-9.62 |
||
2 |
1.71 |
-1.44 |
733728 |
-7.38 |
|||
3 |
1.68 |
0.81 |
654443 |
4.22 |
|||
Mean |
(-) |
1.70 |
-0.82 |
(-) |
712395 |
-4.26 |
|
Control |
1 |
1.69 |
690767 |
||||
2 |
1.68 |
654505 |
|||||
3 |
1.72 |
742974 |
|||||
4 |
1.66 |
633182 |
|||||
5 |
1.71 |
737848 |
|||||
6 |
1.67 |
640573 |
|||||
Mean |
1.69 |
683308 |
negative inhibitions = increase of growth
#) significance caused by increase of growth
Section-by-Section and Average Specific Growth Rates of 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 |
1.24 |
1.98 |
1.86 |
1.69 |
0.396 |
23.4 |
22.7 |
2 |
1.34 |
1.87 |
1.82 |
1.68 |
0.292 |
17.5 |
||
3 |
1.44 |
1.81 |
1.90 |
1.72 |
0.247 |
14.4 |
||
4 |
1.21 |
1.91 |
1.87 |
1.66 |
0.391 |
23.5 |
||
5 |
1.14 |
2.01 |
2.00 |
1.72 |
0.499 |
29.1 |
||
6 |
1.12 |
1.93 |
1.96 |
1.67 |
0.476 |
28.5 |
||
Mean |
1.69 |
|
||||||
SD ± |
0.02 |
|
||||||
CV [%] |
1.38 |
|
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this study N-[3-(dimethylamino)propyl]stearamide was found to inhibit the growth of the freshwater green alga Desmodesmus subspicatus after 72 hours with the following effect values: The NOEC-values for both inhibition of growth rate and yield after 72 hours were 31.6 µg/L. The LOEC-values for both inhibition of growth rate and yield after 72 hours were 100 µg/L. The EC50-value for inhibition of growth rate (ErC50) after 72 hours was 140 (130 – 154) µg/L. The EC50-value for inhibition of yield (EyC50) with 95 % confidence intervals after 72 hours was 74.3 (68.1 – 82.0) µg/L.
All effect levels are given based on nominal concentrations of N-[3-(dimethylamino)propyl]stearamide. - Executive summary:
The toxicity of N-[3-(dimethylamino)propyl]stearamide (batch number: PA02309460) to the unicellular freshwater green alga Desmodesmus subspicatus was determined according to the principles of OECD 201 (2006) at Dr.U.Noack-Laboratorienin 31157 Sarstedt, Germany from 2013-02-04 to 2013-02-13, with the definitive exposure phase from to The aim of the study was to assess the effects on growth rate and yield in natural river water over a period of 72 hours.
The study was conducted under static conditions with an initial cell density of 4332 cells/mL. Based on a preliminary test, 5 concentration levels were tested in a geometrical series with a dilution factor of (nominal): 10.0 - 31.6 - 100 - 316 - 1000 µg/L. Three replicates were tested for each test item concentration and six replicates for the control. Environmental conditions were determined to be within the acceptable limits.
N-[3-(dimethylamino)propyl]stearamide is a tertiary straight chain amine. The test item had low water solubility and sorbed to organic and inorganic materials by different mechanisms. The sorption processes are mostly non-linear, means are concentration dependent. Due to these properties the test item was difficult to test in artificial water (e.g. sorption to the test organism and walls of the test vessel). Natural river water contained particulate as well as dissolved organic carbon to which the test item could sorb partially preventing that the test item settled onto surfaces. The sorbed fraction of the test item was difficult to extract from the test system which normally led to low analytical recoveries. Nevertheless the test item was present in the test system and therefore available for exposure (dissolved in water and sorbed). Sorption of the test item to the glass ware of the test system was monitored as appropriate. Due to the properties of the test item nominal concentrations were used instead of measured ones.
All test concentrations of N-[3-(dimethylamino)propyl]stearamide and the control were analytically verified by LC-MS/MS analysis at the start of the exposure (0 h) and the end of the exposure (72 h).
The measured concentrations of N-[3-(dimethylamino)propyl]stearamide at the start of the exposure were in the range of 95 % to 117 % of the nominal values. At the end of the exposure, they were in the range of LOQM to 2 %. The adsorption samples were analytically verified by LC-MS/MS at the end of the exposure. Adsorption to the glass walls were in the range % for samples with algae and at 13 % for the sample without algae.NOEC, LOEC, EC - values and 95 % Confidence Intervals of N-[3-(dimethylamino)propyl]stearamide
(0-72 hours)based on nominal test item concentrations [µg/L]
Growth Rate Inhibition
NOEC
31.6
LOEC
100
ErC10
70.8 (62.7 – 78.7)
ErC20
89.8 (82.9 – 96.7)
ErC50
140 (130 – 154)
Yield Inhibition
NOEC
31.6
LOEC
100
EyC10
44.9 (40.8 – 49.0)
EyC20
50.9 (46.7 – 55.3)
EyC50
74.3 (68.1 – 82.0)
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