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EC number: 947-827-1 | 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
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- Nanomaterial pour density
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- 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

Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2016-07-12 to 2016-07-15, with the definitive exposure phase from 2016-07-13 to 2016-07-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (4E)-2-[2-hydroxy-2-(3-methylbutoxy)ethyl]-3-methyltridec-4-enoic acid; (4E)-3-methyl-2-[2-(3-methylbutoxy)-2-oxoethyl]dodec-4-enoic acid
- Molecular formula:
- C18H32O4 - C22H40O4
- IUPAC Name:
- (4E)-2-[2-hydroxy-2-(3-methylbutoxy)ethyl]-3-methyltridec-4-enoic acid; (4E)-3-methyl-2-[2-(3-methylbutoxy)-2-oxoethyl]dodec-4-enoic acid
- Test material form:
- liquid: viscous
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 UPLC-DAD at the start (0 hours) and at the end of the exposure (48 hours). The method was validated prior to this study according to SANCO 3029/99 rev.4 (2000).
Sampling for the analytical monitoring
At the start of the exposure (0 hours), sampling was carried out after preparation of the test item concentrations. At the end of the exposure (48 hours), samples were taken directly from the test vessels.
Quality criteria
Recoveries of the test item should be within ± 20% of the nominal or initially measured concentrations.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Preparation of the saturated solution
A saturated solution with a nominal concentration of 193 mg/L of the
test item, which corresponds to 199 µL/L (density taken into account) of the test item, was prepared one day prior to the start of the exposure (at -24 hours) in a glass flask with a lateral outlet (nominal capacity: 1 L).
The glass flask was filled with 1 L of the dilution water. The test item (199 µL) was placed by pipette onto the water surface. A slow stirring procedure was applied. Gentle stirring (to avoid formation of an emulsion) was carried out for 24 ± 1 hours with a magnetic stirrer at room temperature. After completion of stirring, the saturated solution was allowed to stand for 1 hour for separation of undissolved test item. The saturated solution was removed by the lateral outlet of the flask (from the approximate bottom of the glass flask). Due to the density of the test item, any undissolved material was expected to float on the surface. The saturated solution was checked via laser beam (Tyndall effect) for undissolved test item (formation of emulsion), which could not be observed. The saturated solution was used as the highest concentration level and as a stock solution for the preparation of further dilution levels by dilution with dilution water.
Test concentrations / solutions
5 test item concentrations in a geometric series with a separation factor of 2, prepared by diluting the saturated solution with dilution water, were tested as follows: 6.25 - 12.5 - 25 - 50 - 100% of the saturated solution
The test concentrations were selected based on the results of a non-GLP preliminary range finding test.
Control
Dilution water without test item incubated under the same conditions as the test groups
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Test system
Daphnia magna STRAUS (Clone 5)
Reason for the selectionof the test system
Daphnia magna is the preferred species in accordance with the
test guideline and is bred at the test facility.
Origin
Institut für Wasser-, Boden- und Lufthygiene (WaBoLu),
14195 Berlin, Germany
Breeder
Noack Laboratorien GmbH,
Käthe-Paulus-Str. 1, 31157 Sarstedt, Germany
Culture
In glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20 2 °C, in an incubator, 16 hours illumination; light intensity of max. 1500 lx
Culture medium
Elendt M4, according to OECD 202, Annex 3 (2004), modified to a total hardness of 160 to 180 mg CaCO3/L, is used.
Culture feeding
The culture daphnids were fed at least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus, with an algae cell density of > 106 cells/mL. The algae were cultured at the test facility.
Origin of the food algae
Sammlung von Algenkulturen (SAG),
Pflanzenphysiologisches Institut der Universität Göttingen, Nikolausberger Weg 18, 37073 Göttingen, Germany
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- see any other information on material and methods incl. tables
- Test temperature:
- see any other information on material and methods incl. tables
- pH:
- see any other information on material and methods incl. tables
- Dissolved oxygen:
- see any other information on material and methods incl. tables
- Conductivity:
- see any other information on material and methods incl. tables
- Nominal and measured concentrations:
- Nominal: 6.25 - 12.5 - 25.0 - 50.0 - 100% of the saturated solution
Geometric mean measured test item concentrations: 1-30 - 2.18 - 3.68 - 6.66 - 13.9 mg/L. - Details on test conditions:
- Test method
Based on the results of a preliminary range finding test, the study was performed with a static test design, since the measured concentrations remained stable over 48 hours under test conditions..
Test duration
48 hours
Test vessels
Glass beakers (4 (ID) x 7 (H) cm), 50 mL capacity, loosely covered with watch glasses
Test volume
20 mL in each test replicate (see ‘Application’)
Dilution water
Same as culture medium
Number of daphnids and replicates
20 daphnids, divided into 4 replicates, each with 5 daphnids, were used for each loading level and the control.
Age of the daphnids
Less than 24 hours old daphnids from a healthy stock were used for at the start of the exposure the study. Juvenile daphnids were removed from the culture vessels at the latest 24 hours before the start of the exposure and discarded. The juveniles born within the following period of max. 24 hours preceding the exposure were used for the test. No first brood progeny was used for the test.
Acclimatization
Acclimatization of the daphnids was not necessary, because the dilution water was equivalent to the culture medium.
Application
20 g test solution per replicate was weighed out into each test vessel. This corresponds to 20 mL per test vessel. The daphnids were inserted with a small amount of dilution water by a pipette.
Test temperature (target)
18 - 22 °C, constant within ± 1 °C
Illumination (target)
Diffuse light, light intensity of max. 1500 lx
Photoperiod (target)
16/8 hours light/dark cycle
Feeding
The daphnids were not fed during the study. - Reference substance (positive control):
- yes
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- EC10
- Effect conc.:
- 6.64 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: CI: 5.16 - 8.66
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 6.22 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: CI: < 2.18 - 11.2
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 9.76 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: CI: 8.39 - 11.2
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 8.03 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: CI: 6.90 - 12.0
- Duration:
- 24 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 13.9 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- 13.9 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- The concentrations of the test item Tetrapropylene succinic acid monoisobutylester were analytically verified via HPLC-DAD at the start (0 hours) and at the end of the exposure (48 hours) in all concentration levels and in the control.
The measured concentrations of the test item were in the range of 85 to 102% of the 0 hour measured concentrations at 48 hours at the biologically most relevant concentration levels of 12.5 to 100% of the saturated solution. The analytical results reflected the dilution factor of 2 between the concentration levels. At the two lowest concentration levels 6.25 and 12.5% of the saturated solution, the measured values were below the LOQ. Since the concentration level of 6.25% of the saturated solution was below the EC0, it was excluded from further evaluation. At the concentration level of 12.5% of the saturated solution, the measured concentrations were > 70% of the LOQ and were therefore used for the evaluation.
The measured test item concentrations remained stable within ± 20% of the 0 hour measured concentrations at 48 hours at the biologically most relevant concentration levels of 12.5 to 100% of the saturated solution. This indicates that the test item concentrations were successfully maintained for the duration of the test. The effect levels given are based on the geometric mean measured concentrations of the test item Tetrapropylene succinic acid monoisobutylester.
The geometric mean measured concentrations of the biologically most relevant concentration levels were determined to be 2.18 - 3.68 - 6.66 - 13.9 mg/L. - Results with reference substance (positive control):
- The percentage of immobility for the reference item was determined after 24 hours. The EC50-value with 95% confidence limits (CI) was calculated by sigmoidal dose-response regression. The EC50-value for the most recent of the monthly performed reference tests was:
EC50: 2.00 mg/L (Cl: 1.22 - 3.29 mg/L)
The EC50-value of the reference item potassium dichromate after 24 hours is within the required concentration range of 0.6 - 2.4 mg/L of quality criteria according to AQS P 9/2 (02/2000) for daphnids clone 5 cultured in Elendt M4 medium. The EC50-value of the reference item is also within the recommended range of 0.6 - 2.1 mg/L according to OECD-Guideline 202. - Reported statistics and error estimates:
- Methods of evaluation
The EC100-values after 24 and 48 hours were estimated directly from the observation data.
The effect levels (EC10 / 50 / 100) given are based on the geometric mean measured concentrations of the test item.
EC-values and statistical analyses
The EC10- and the EC50-values after 24 and 48 hours were calculated by sigmoidal dose-response regression. The respective 95% confidence limits were calculated from the standard error and the t distribution. All calculations were carried out from the best-fit values with the software GraphPad Prism5. The concentration-effect relationships of the test item are shown graphically.
The EC50-value for the reference item and its confidence limits were calculated accordingly.
Software alculation
All data were computer-processed and rounded for presentation. Consequently, minor variations may occur from the original figures if manual calculations based on the original figures are made subsequently. Calculations were made using the following software:
- GraphPad Prism5, GRAPHPAD SOFTWARE, INC.
- Excel, MICROSOFT CORPORATION
Any other information on results incl. tables
Immobilization Ratesafter 24 and 48 hours ofExposure in the Definitive Test
(n = 20, divided into 4 replicates with 5 daphnids each)
Geometric mean measured concentration of the test item [mg/L] |
IMMOBILIZATION [%] |
|||||||||
24 hours |
48 hours |
|||||||||
Replicates |
Replicates |
|||||||||
1 |
2 |
3 |
4 |
MV |
1 |
2 |
3 |
4 |
MV |
|
13.9 |
80 |
80 |
100 |
100 |
90 |
100 |
100 |
100 |
100 |
100 |
6.66 |
0 |
0 |
20 |
20 |
10 |
20 |
0 |
20 |
20 |
15 |
3.68 |
20 |
0 |
0 |
0 |
5 |
40 |
0 |
0 |
0 |
20 |
2.18 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1.30* |
|
|
|
|
|
|
|
|
|
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
* = concentration excluded from evaluation (below EC0and measured concentrations < 70% of the LOQ)
Measured Exposure Concentrations during the Definitive Test
The concentrations of the test itemTetrapropylenesuccinic acid monoisobutylester were analytically verified via HPLC-DAD at the start (0 hours) and at the end of the exposure (48 hours) in all concentration levels and in the control. The signal was confirmed by a NON-GLP LC-MS/MS analysis (details given in a Statement of Noack Laboratories: 151110CB / CKK16906).
The measured concentrations of the test item were in the range of 85 to 102% of the 0 hour measured concentrations at 48 hours at the biologically most relevant concentration levels of 12.5 to 100% of the saturated solution. The analytical results reflected the dilution factor of 2 between the concentration levels. At the two lowest concentration levels 6.25 and 12.5% of the saturated solution, the measured values were below the LOQ. Since the concentration level of 6.25% of the saturated solution was below the EC0,it was excluded from further evaluation. At the concentration level of 12.5% of the saturated solution, the measured concentrations were > 70% of the LOQ and were therefore used for the evaluation.
The measured test item concentrations remained stable within±20% of the 0 hour measured concentrations at 48 hours at the biologically most relevant concentration levels of 12.5 to 100% of the saturated solution. This indicates that the test item concentrations were successfully maintained for the duration of the test.
The geometric mean measured concentrations of the biologically most relevant concentration levels were determined to be 2.18 - 3.68 - 6.66 - 13.9 mg/L.
Table6: Measured Concentrations of the Test ItemTetrapropylenesuccinic acid monoisobutylesterduring the Definitive Test
Sampling date |
2016-07-13 Start of the exposure, |
2016-07-15 End of the exposure, |
|
|
Start of analysis |
2016-07-13 |
2016-07-15 |
|
|
Nominal concentration of the saturated solution [%] |
Tetrapropylenesuccinic acid monoisobutylester |
Geometric mean measured concentration [mg/L] |
||
Meas. conc. [mg/L] |
Meas. conc. [mg/L] |
% |
||
100 |
13.8 |
14.1 |
102 |
13.9 |
50 |
6.70 |
6.63 |
99 |
6.66 |
25 |
3.98 |
3.40 |
85 |
3.68 |
12.5 |
2.181) |
2.191) |
100 |
2.181) |
6.25 |
< LOQ |
< LOQ |
1.302) |
|
Control |
< LOQ |
< LOQ |
|
Meas. conc.= measured concentration of the test item, mean value of 2 injections, dilution factors taken into account
% = percent of the initially measured concentration of the test item
LOQ = limit of quantification of the analytical method (2.60 mg/L of the test item)
1) = < LOQ, but > 70% LOQ
2) = set to ½ of the LOQ, since measured values were < 70% of the LOQ
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the geometric mean measured concentrations of the test item, the 48 hour-EC50 for Daphnia magna was 8.03 mg/L (95% confidence limits: 6.90 – 12.0 mg/L).
- Executive summary:
In the acute immobilization test withDaphnia magna (STRAUS), the effects of the test item were determined at the test facility according to OECD 202 (2004) from2016-07-12 to 2016-07-15, with the definitive exposure phase from 2016-07-13 to 2016-07-15.
The study was conducted under static conditions over a period of 48 hours with a saturated solution (prepared with a nominal concentration of 199 µL/Lof the test itemTetrapropylenesuccinic acid monoisobutylester) and further four dilution levels prepared in a geometric series with a separation factor of2(nominal concentrations of6.25 to 100%of the saturated solution).
Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to each concentration leveland the control.
The concentrations of the test itemTetrapropylenesuccinic acid monoisobutylesterwere analytically verified via HPLC-DAD at the start (0 hours) and at the end of the exposure (48 hours) in all concentration levels and in the control. Details of the analytical method are presented in section14.
The measured concentrations of the test item were in the range of 85 to 102% of the 0 hour measured concentrations at 48 hours at the biologically most relevant concentration levels of 12.5 to 100% of the saturated solution. The analytical results reflected the dilution factor of 2 between the concentration levels. At the two lowest concentration levels 6.25 and 12.5% of the saturated solution, the measured values were below the LOQ. Since the concentration level of 6.25% of the saturated solution was below the EC0,it was excluded from further evaluation. At the concentration level of 12.5% of the saturated solution, the measured concentrations were > 70% of the LOQ and were therefore used for the evaluation.The analytical results arepresented inTable 6.
The measured test item concentrations remained stable within±20% of the 0 hour measured concentrations at 48 hours at the biologically most relevant concentration levels of 12.5 to 100% of the saturated solution. This indicates that the test item concentrations were successfully maintained for the duration of the test. The effect levels given are based on the geometric mean measured concentrations of the test itemTetrapropylenesuccinic acid monoisobutylester.
The geometric mean measured concentrations of the biologically most relevant concentration levels were determined to be 2.18 - 3.68 - 6.66 - 13.9 mg/L.
The validity criteria of the test guideline were fulfilled.
Table1: EC10-, EC50- (with 95% Confidence Limits) and EC100-Values
(based on the geometric mean measured concentrations of the test item)
Effect levels
Test duration
[h]
Tetrapropylenesuccinic acid monoisobutylester
Geometric mean measured test item concentrations
[mg/L]
EC10
(with 95% confidence limits)
24
6.64
(Cl: 5.16 – 8.66)
48
6.22
(Cl: < 2.18 – 11.2)
EC50
(with 95% confidence limits)
24
9.76
(Cl: 8.39 – 11.2)
48
8.03
(Cl: 6.90 – 12.0)
EC100
24
> 13.9
48
13.9
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