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EC number: 701-162-1 | 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
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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:
- 2013-01-28 to 2013-02-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study, no deficiencies
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:
- 6-[3-(C12-C18)-alkenyl(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid
- EC Number:
- 701-162-1
- Molecular formula:
- C22H37NO4 - C28H49NO4
- IUPAC Name:
- 6-[3-(C12-C18)-alkenyl(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid
- Details on test material:
- - Name of test material (as cited in study report): (Pentapropylensuccinimido)-capronic acid
- Physical state: Liquid, brown viscous
- Analytical purity: 95.0 % (w/w) (100 % minus by-products)
- Purity test date: 2011-11-15
- Lot/batch No.: ESD0009272
- Expiration date of the lot/batch: 2014-04-26
- Stability under test conditions: Not specified
- Storage condition of test material: Room temperature, protected from light, in original container
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 7.50 - 15.0 - 30.0 - 60.0 - 120 mg/L
- Sampling method: Each test item concentration and the control were analytically verified at the beginning and at the end of the test. Analytical evaluation of (Pentapropylensuccinimido)-capronic acid was carried out via LC-MS/MS. Samples at test start were taken from additional replicate without algae. At end of the test the samples were taken directly from the pooled test replicates.
- Sample storage conditions before analysis: All original samples were stored at room temperature until sample preparation. 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 dilution water. Dispersion treatment was agitation.
- Eluate: Dilution water
- Differential loading: 1.00 - 3.16 - 10.0 - 31.6 - 100 mg/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
- Hardness:
- 0.24 mmol Ca+Mg/l
- Test temperature:
- min.: 21.0 max.: 22.5, mean value: 21.75 °C
- pH:
- Geometric mean measured
test item concentration pH-value
[mg/L] Start; 0 hours End; 72 hours
82.2 7.75 8.14
41.3 7.85 8.20
10.4 7.94 8.26
9.26 7.95 8.34
2.17 7.99 8.41
Control 8.05 8.47 - 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 653967 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: 67.9
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 [%]
100 59 98
20.0 2 26
10.00 -1 -3
1.00 0 1
0.10 0 2
- Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 38 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI 33.5-42.6 mg/L
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 9.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI 8.4-10.9 mg/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
Current 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 was 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.
Detection of statistically significant differences were considered negligible when inhibition values were ≤ 10 %. These findings were marked “biologically not significant”. Following the recommendations of the UBA (HEGER ET AL. 1998), inhibitions > 10 % are significant.
Any other information on results incl. tables
Cell Densities
|
Geometric mean measured test item concentration |
Replicate |
Cell density [cells/mL] |
||||||
[mg/L] |
No. |
0 hours |
24 hours |
48 hours |
72 hours |
|
|||
82.2 |
1 |
4332 |
8304 |
10150 |
17971 |
|
|||
2 |
4332 |
8769 |
10263 |
19736 |
|
||||
3 |
4332 |
7747 |
12078 |
22632 |
|
||||
Mean |
4332 |
8273 |
10830 |
20113 |
|
||||
41.3 |
1 |
4332 |
8593 |
23161 |
48110 |
|
|||
2 |
4332 |
6549 |
20377 |
47289 |
|
||||
3 |
4332 |
8929 |
21009 |
46493 |
|
||||
Mean |
4332 |
8024 |
21516 |
47297 |
|
||||
10.4 |
1 |
4332 |
13380 |
53142 |
263766 |
|
|||
2 |
4332 |
14628 |
68729 |
351574 |
|
||||
3 |
4332 |
14241 |
63970 |
338585 |
|
||||
Mean |
4332 |
14083 |
61947 |
317975 |
|
||||
9.26 |
1 |
4332 |
16707 |
73418 |
452705 |
|
|||
2 |
4332 |
14993 |
79085 |
459073 |
|
||||
3 |
4332 |
16597 |
78664 |
512821 |
|
||||
Mean |
4332 |
16099 |
77056 |
474866 |
|
||||
2.17 |
1 |
4332 |
19245 |
139035 |
769252 |
|
|||
2 |
4332 |
20654 |
137393 |
805262 |
|
||||
3 |
4332 |
21944 |
142221 |
887001 |
|
||||
Mean |
4332 |
20614 |
139550 |
820505 |
|
||||
Control |
1 |
4332 |
22072 |
120520 |
670027 |
|
|||
2 |
4332 |
18789 |
106953 |
667480 |
|
||||
3 |
4332 |
19339 |
112529 |
615556 |
|
||||
4 |
4332 |
17333 |
116224 |
648295 |
|
||||
5 |
4332 |
19198 |
118810 |
700314 |
|
||||
6 |
4332 |
23758 |
112642 |
622129 |
|
||||
Mean |
4332 |
20082 |
114613 |
653967 |
|
Evaluation after 72 hours
Statistically significant differences of growth rates and yield compared to
control values are marked (+), not significant differences are marked (-).
Geometric mean measured test item concentration |
Replicate |
Growth rate |
Rate-related inhibition |
Yield |
Inhibition of yield |
||
[mg/L] |
No. |
[d-1] |
[%] |
[cells/mL] |
[%] |
||
82.2 |
1 |
0.474 |
71.6 |
13639 |
97.9 |
||
2 |
0.505 |
69.8 |
15404 |
97.6 |
|||
3 |
0.551 |
67.0 |
18300 |
97.2 |
|||
Mean |
(+) |
0.510 |
69.5 |
(+) |
15781 |
97.6 |
|
41.3 |
1 |
0.802 |
52.0 |
43778 |
93.3 |
||
2 |
0.797 |
52.4 |
42957 |
93.4 |
|||
3 |
0.791 |
52.7 |
42161 |
93.5 |
|||
Mean |
(+) |
0.797 |
52.4 |
(+) |
42965 |
93.4 |
|
10.4 |
1 |
1.37 |
18.1 |
259434 |
60.1 |
||
2 |
1.47 |
12.4 |
347242 |
46.6 |
|||
3 |
1.45 |
13.1 |
334253 |
48.6 |
|||
Mean |
(+) |
1.43 |
14.5 |
(+) |
313643 |
51.7 |
|
9.26 |
1 |
1.55 |
7.31 |
448373 |
31.0 |
||
2 |
1.55 |
7.03 |
454741 |
30.0 |
|||
3 |
1.59 |
4.83 |
508489 |
21.7 |
|||
Mean |
(+)1) |
1.57 |
6.39 |
(+) |
470534 |
27.6 |
|
2.17 |
1 |
1.73 |
-3.26 |
764920 |
-17.8 |
||
2 |
1.74 |
-4.17 |
800930 |
-23.3 |
|||
3 |
1.77 |
-6.10 |
882669 |
-35.9 |
|||
Mean |
(+)2) |
1.75 |
-4.51 |
(+)2) |
816173 |
-25.6 |
|
Control |
1 |
1.68 |
665695 |
||||
2 |
1.68 |
663148 |
|||||
3 |
1.65 |
611224 |
|||||
4 |
1.67 |
643963 |
|||||
5 |
1.70 |
695982 |
|||||
6 |
1.66 |
617797 |
|||||
Mean |
1.67 |
649635 |
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 h) |
SD ± |
CV |
Mean CV [%] |
|||
section-by-section |
||||||||
0 - 24 hours |
24 - 48 hours |
48 - 72 hours |
||||||
Control |
1 |
1.63 |
1.70 |
1.72 |
1.68 |
0.0461 |
2.74 |
8.99 |
2 |
1.47 |
1.74 |
1.83 |
1.68 |
0.189 |
11.3 |
||
3 |
1.50 |
1.76 |
1.67 |
1.65 |
0.139 |
8.39 |
||
4 |
1.39 |
1.90 |
1.72 |
1.67 |
0.262 |
15.7 |
||
5 |
1.49 |
1.82 |
1.77 |
1.70 |
0.180 |
10.6 |
||
6 |
1.70 |
1.56 |
1.71 |
1.66 |
0.0862 |
5.20 |
||
Mean |
1.67 |
|
||||||
SD ± |
0.02 |
|
||||||
CV [%] |
0.97 |
|
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this study (Pentapropylensuccinimido)-capronic acid was found to inhibit the growth of the freshwater green alga Desmodesmus subspicatus after 72 hours with the following effect values (geometric mean measured test item concentrations). The NOEC-values for inhibition of growth rate and yield after 72 hours were 9.26 and 2.17 mg/L, respectively. The LOEC-values for inhibition of growth rate and yield after 72 hours were 10.4 and 9.26 mg/L, respectively. The EC50-values for inhibition of specific growth rate (ErC50) and yield (EyC50) with 95 % confidence intervals after 72 hours were 38.0 (33.5 – 42.6) and 10.3 (10.0 – 10.8) mg/L, respectively.
All effect levels are given based on geometric mean measured concentrations of (Pentapropylensuccinimido)-capronic acid. - Executive summary:
The toxicity of (Pentapropylensuccinimido)-capronic acid (batch number: ESD0009272)to the unicellular freshwater green alga Desmodesmus subspicatus was determined according to the principles of OECD 201 at Dr.U.Noack-Laboratorienin 31157 Sarstedt, Germany from 2013-01-28 to 2013-02-01, with the definitive exposure phase from 2013-01-29 to 2013-02-01. The aim of the study was to assess 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 4332 cells/mL. Based on a preliminary test 5 concentration levels were tested in a geometrical series with a dilution factor of 2 (nominal): 7.50 - 15.0 - 30.0 - 60.0 - 120 mg/L, corresponding to geometric mean measured test item concentrations of 2.17 - 9.26 - 10.4 - 41.3 - 82.2 mg/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.
Various test concentrations of (Pentapropylensuccinimido)-capronic acid and the control were analytically verified by LC-MS/MS at test start and test end.
The measured concentrations of (Pentapropylensuccinimido)-capronic acid at test start were in the range of 28 to 77 % of the nominal values. After 72 hours the measured concentrations of (Pentapropylensuccinimido)-capronic acid were in the range of 30 to 66 %. Therefore, all effect values given are based on the geometric mean measured concentrations of the test item (Pentapropylensuccinimido)-capronic acid.
NOEC, LOEC, EC - values and 95 % Confidence Intervals of
(Pentapropylensuccinimido)-capronic acid(0-72 hours)based on geometric mean measured test item concentrations [mg/L]
Growth Rate Inhibition
NOEC
9.26
LOEC
10.4
ErC10
9.59 (8.42 – 10.9)
ErC20
14.6 (13.2 – 16.3)
ErC50
38.0 (33.5 – 42.6)
Yield Inhibition
NOEC
2.17
LOEC
9.26
EyC10
8.46 (7.74 – 8.90)
EyC20
8.92 (8.34 – 9.25)
EyC50
10.3 (10.0 – 10.8)
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