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EC number: 241-477-7 | CAS number: 17463-34-2
- 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:
- 2016-05-09 to 2016-05-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octanoic acid, compound with octylamine (1:1)
- EC Number:
- 241-477-7
- EC Name:
- Octanoic acid, compound with octylamine (1:1)
- Cas Number:
- 17463-34-2
- Molecular formula:
- C8H19N.C8H16O2
- IUPAC Name:
- octan-1-amine; octanoic acid
- Test material form:
- other: Pale brown, waxy solid
- Details on test material:
- Test Item: Caprylamine caprylate
Chemical name: Octanoic acid, compound with octylamine
CAS number: 17463-34-2
Molecular formula: C8H19N.C8H16O2
Molecular weight: 273.5 g/mol
Appearance: Pale brown, waxy solid
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Determination of the test item
All concentration levels and the control were analytically verified via LC-MS/MS at the start (0 hours) and at the end of the exposure (72 hours) with algae.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Stock solution
100 mg test item/L were freshly prepared with dilution water.
Dispersion treatment
Agitation until the solution is visually clear
Test concentrations
5 concentrations were tested in a geometrical series with a dilution factor of √10: 0.100 - 0.316 - 1.00 - 3.16 - 10.0 mg/L.
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
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata HINDÁK
- Strain: SAG 61.81
- Source (laboratory, culture collection): SAG, Pflanzenphysiologisches Institut der Universität Göttingen, Nikolausberger Weg 18, D-37073 Göttingen
- Age of inoculum (at test initiation): 3 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
- Hardness:
- Not specified
- Test temperature:
- min.: 23.0 max.: 24.0 mean value: 23.5
- pH:
- Nominal test item concentration pH-value
[mg/L] Start; 0 hours End; 72 hours
10.0 8.09 8.19
3.16 8.13 8.24
1.00 8.01 9.01
0.316 8.06 9.41
0.100 8.02 9.48
Control 8.12 9.52 - Dissolved oxygen:
- Not measured
- Salinity:
- Not measured, freshwater conditions
- Nominal and measured concentrations:
- The measured concentrations of Caprylamine caprylate in the fresh media (0 h) were in the range of 114 to 120 % of the nominal values at all tested concentration levels. The measured concentrations in the old media (72 h) were in the range of 82 to 115 % of the nominal values of all concentrations. Therefore, the nominal concentrations of the test item were used for the calculations.
- 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 5 x 10^3 - 10^4 cells/mL, Actual: mean 6305 cells/mL
- Control end cells density: Mean 2289490 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 0.064
Na2EDTA 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: 4440 - 8880 lux, mean value: 5518 lux,
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. - Reference substance (positive control):
- yes
- Remarks:
- (Potassium dichromate)
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.316 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.68 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: CI 0.476 - 0.865
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- 0.835 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: CI 0.626 - 0.929
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.15 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: CI 1.06 - 1.65
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.316 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.22 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Remarks on result:
- other: CI <0.100 - 0.301
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- 0.303 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield
- Remarks on result:
- other: CI 0.237 - 0.384
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.504 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Yield
- Remarks on result:
- other: CI 0.417 - 0.625
- 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
- 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 2016-04-26 to 2016-04-29 (with headspace). 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 0.460 0.780 ± 0.473
95 % confidence interval 0.443 – 0.481
Yield inhibition
EyC50 0.317 0.411 ± 0.276
95 % confidence interval 0.208 – 0.347
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- and LOEC-values
The NOEC / LOEC was determined by calculation of statistical significance of growth rate and yield. The following statistical tests were conducted:
Shapiro-Wilk’s test on normal distribution was done with a significance level 0.01.
Levene’s test on variance homogeneity was done with a significance level 0.01.
Monotonicity was done by trend analysis by contrasts (significance level 0.05).
William’s multiple sequential t-test procedure was done with a significance level 0.05.
Welsh-t-test after Bonferroni-Holm was done with a significance level of 0.05.
Software
The data for the tables in this report were computer-generated and have been rounded for presentation from the fully 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.
- ToxRat, ToxRat Solutions GmbH
- GraphPad Prism, GRAPHPAD SOFTWARE, INC.
Any other information on results incl. tables
Cell Densities
Nominal test item concentration |
Replicate |
Cell density [cells/mL] |
|||||||||
[mg/L] |
No. |
0 hours |
24 hours |
48 hours |
72 hours |
||||||
10.0 |
1 |
6305 |
2787 |
<LOQ |
<LOQ |
||||||
2 |
6305 |
2852 |
<LOQ |
<LOQ |
|||||||
3 |
6305 |
3325 |
<LOQ |
<LOQ |
|||||||
Mean |
6305 |
2988 |
n.a. |
n.a. |
|||||||
3.16 |
1 |
6305 |
9116 |
3872 |
<LOQ |
||||||
2 |
6305 |
9668 |
3503 |
<LOQ |
|||||||
3 |
6305 |
9138 |
3365 |
<LOQ |
|||||||
Mean |
6305 |
9307 |
3580 |
n.a. |
|||||||
1.00 |
1 |
6305 |
28547 |
56951 |
197151 |
||||||
2 |
6305 |
28068 |
80563 |
383899 |
|||||||
3 |
6305 |
31391 |
67779 |
318233 |
|||||||
Mean |
6305 |
29335 |
68431 |
299761 |
|||||||
0.316 |
1 |
6305 |
27391 |
301776 |
1795874 |
||||||
2 |
6305 |
25984 |
316559 |
2195664 |
|||||||
3 |
6305 |
34749 |
219562 |
1375448 |
|||||||
Mean |
6305 |
29375 |
279299 |
1788995 |
|||||||
0.100 |
1 |
6305 |
33201 |
418826 |
2151632 |
||||||
2 |
6305 |
33060 |
439320 |
2346312 |
|||||||
3 |
6305 |
29770 |
406028 |
2206940 |
|||||||
Mean |
6305 |
32010 |
421391 |
2234961 |
|||||||
Control |
1 |
6305 |
29240 |
315882 |
2280460 |
||||||
2 |
6305 |
44159 |
480652 |
2251650 |
|||||||
3 |
6305 |
36761 |
435875 |
2304478 |
|||||||
4 |
6305 |
29796 |
353414 |
2206320 |
|||||||
5 |
6305 |
40714 |
428805 |
2172774 |
|||||||
6 |
6305 |
43730 |
492487 |
2521259 |
|||||||
Mean |
6305 |
37400 |
417853 |
2289490 |
< 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] |
[%] |
||
10.0 |
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 |
|
3.16 |
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 |
|
1.00 |
1 |
|
1.15 |
42 |
|
190846 |
92 |
2 |
|
1.37 |
30 |
|
377594 |
83 |
|
3 |
|
1.31 |
33 |
|
311928 |
86 |
|
Mean |
(+) |
1.28 |
35 |
(+) |
293456 |
87 |
|
0.316 |
1 |
|
1.88 |
4 |
|
1789569 |
22 |
2 |
|
1.95 |
1 |
|
2189359 |
4 |
|
3 |
|
1.80 |
9 |
|
1369143 |
40 |
|
Mean |
(-) |
1.88 |
4 |
(+) |
1782690 |
22 |
|
0.100 |
1 |
|
1.94 |
1 |
|
2145327 |
6 |
2 |
|
1.97 |
0 |
|
2340007 |
-2 |
|
3 |
|
1.95 |
1 |
|
2200635 |
4 |
|
Mean |
(-) |
1.96 |
0 |
(-) |
2228656 |
2 |
|
Control |
1 |
|
1.96 |
|
|
2274155 |
|
2 |
|
1.96 |
|
|
2245345 |
|
|
3 |
|
1.97 |
|
|
2298173 |
|
|
4 |
|
1.95 |
|
|
2200015 |
|
|
5 |
|
1.95 |
|
|
2166469 |
|
|
6 |
|
2.00 |
|
|
2514954 |
|
|
Mean |
|
1.97 |
|
|
2283185 |
|
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 |
1.53 |
2.38 |
1.98 |
1.96 |
0.423 |
21.5 |
21.4 |
2 |
1.95 |
2.39 |
1.54 |
1.96 |
0.422 |
21.5 |
||
3 |
1.76 |
2.47 |
1.67 |
1.97 |
0.441 |
22.4 |
||
4 |
1.55 |
2.47 |
1.83 |
1.95 |
0.472 |
24.2 |
||
5 |
1.87 |
2.35 |
1.62 |
1.95 |
0.373 |
19.1 |
||
6 |
1.94 |
2.42 |
1.63 |
2.00 |
0.398 |
19.9 |
||
|
|
|
Mean |
1.97 |
|
|
||
|
|
|
SD ± |
0.02 |
|
|||
|
|
|
CV [%] |
0.89 |
|
SD = Standard deviation CV = Coefficient of variation
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this study, Caprylamine caprylate was found to inhibit the growth of the freshwater green alga Pseudokirchneriella subcapitata after 72 hours with the following effect values (based on the nominal test item concentrations): The NOEC (0-72 h) for inhibition of growth and inhibition of yield was 0.316 and 0.100 mg/L. The EC50-values with 95 % confidence intervals for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were 1.15 (1.06 – 1.65) mg/L and 0.504 (0.417 – 0.625) mg/L, respectively. All effect values are based on the nominal concentrations of Caprylamine caprylate.
- Executive summary:
The toxicity of Caprylamine caprylate to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined according to the principles of OECD 201 and Council Regulation (EC) No. 761/2009/Method C.3 from 2016-05-09 to 2016-05-12 at the test facility. 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 6305 cells/mL. A stock solution of 100 mg/L was freshly prepared with dilution water. Five concnetrations were tested in a geometrical series with a dilutionfactor of √10:0.100 - 0.316 - 1.00 - 3.16 - 10.0 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 Caprylamine caprylate 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 Caprylamine caprylate in the fresh media (0 h) were in the range of 114 to 120 % of the nominal values at all tested concentration levels. The measured concentrations in the old media (72 h) were in the range of 82 to 115 % of the nominal values of all concentrations.Therefore, all effect values given are based on the nominal test item concentrations of Caprylamine caprylate.
NOEC, LOEC, EC-values and 95 % Confidence Intervals ofCaprylaminecaprylate(0 - 72 hours)
based on nominal test item concentrations [mg/L]
Growth RateInhibition
nominal test item concentrations [mg/L]NOEC
0.316
LOEC
1.00
ErC10
0.680 (0.476 – 0.865)
ErC20
0.835 (0.626 – 0.929)
ErC50
1.15 (1.06 – 1.65)
Inhibition of Yield
nominal test item concentrations [mg/L]NOEC
0.100
LOEC
0.316
EyC10
0.220 (<0.100 – 0.301)
EyC20
0.303 (0.237 – 0.384)
EyC50
0.504 (0.417 – 0.625)
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