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EC number: 931-275-3 | CAS number: 1125503-33-4
- 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
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:
- 2008-12-16 to 2008-12-18
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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:
- [see concordance uder 1.1. of the CSR]
- IUPAC Name:
- [see concordance uder 1.1. of the CSR]
- Details on test material:
- - Name of test material (as cited in study report): Praepagen HY
- Molecular weight: 307 g/mol
- Physical state: liquid
- Analytical purity: 39.5 % (w/w, DIN EN ISO 2871-1)
- Lot/batch No.: DEG4036741
- Expiration date of the lot/batch: 2009-06-01
- Storage condition of test material: Room temperature, protected from moisture and light
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0.0625 - 0.125 - 0.250 - 0.500 - 1.00 mg/L
- Sampling method: The concentration levels 0.0625, 0.125 mg/L and the control were analysed directly. The samples of the concentrations levely 0.250 to 1.00 mg/L were diluted with dilution water prior to analysis.
- Sample storage conditions before analysis: All samples were stored at 6 +/- 2 °C if necessary.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The stock solutions (10.0 mg/L test substance were weighed out) were freshly prepared with dilution water prior to application and water renewal.
- Eluate: Dilution water
- Differential loading: 0.0625 - 0.125 - 0.250 - 0.500 - 1.00 mg/L
- Controls: Dilution water without test item tested under the same conditions as the test groups.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna STRAUS (Clone 5)
- Strain: Clone 5
- Source: Own breeding, source: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu)
- Age at study initiation (mean and range, SD): 2 - 24 h old
- Method of breeding: In glass vessels (2-3 L capacity) with approx. 1.8 L culture medium, at 20 +/- 2 °C, in an incubator, 16 h illumination, illumination strength max. 20 µE-m2*s-1. Culture medium Elendt M4 acc. to Elendt, modified to a total hardness of 160 to 180 mg CaCO3
- Feeding during test
- Food type: No feeding during the study
ACCLIMATION
- Acclimation period: At least 2 h in dilution water
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: No food
- Health during acclimation (any mortality observed): No mortality observed
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- Total hardness (Dilution water): 267 mg CaCO3/L (24 h); 263 mg CaCO3/L (48 h)
- Test temperature:
- Temperature: 19 - 20 °C
- pH:
- Water Parameters at 0 h and 24 h (New Media)
(measured in one additional replicate per concentration and control)
Nominal
Test Item Concentration
[mg/L] 0 h 24 h
pH-Value pH-Value
1.00 7.55 7.55
0.500 7.57 7.57
0.250 7.58 7.56
0.125 7.58 7.49
0.0625 7.56 7.51
Control 7.82 7.86
Water Parameters at 24 h (Old Media)
(measured in all replicates)
Nominal
Test Item Concentration
[mg/L] pH-Values
Replicates
1 2 3 4
1.00 7.38 7.45 7.44 7.44
0.500 7.40 7.39 7.41 7.41
0.250 7.39 7.41 7.40 7.40
0.125 7.42 7.41 7.40 7.39
0.0625 7.41 7.40 7.38 7.42
Control 7.35 7.36 7.34 7.33
Water Parameters at 48 h (Old Media)
(measured in all replicates)
Nominal
Test Item Concentration
[mg/L] pH-Values
Replicates
1 2 3 4
1.00 7.47 7.48 n.d. n.d.
0.500 7.47 7.47 7.48 7.47
0.250 7.46 7.48 7.49 7.48
0.125 7.46 7.47 7.49 7.46
0.0625 7.49 7.48 7.47 7.46
Control 7.45 7.52 7.52 7.48 - Dissolved oxygen:
- Water Parameters at 0 h and 24 h (New Media)
(measured in one additional replicate per concentration and control)
Nominal
Test Item Concentration
[mg/L] 0 h 24 h
O2-Concentration [mg/L] O2-Concentration [mg/L]
1.00 8.36 8.14
0.500 8.40 8.23
0.250 8.29 8.06
0.125 8.03 8.11
0.0625 8.30 8.15
Control 8.28 9.15
Water Parameters at 24 h (Old Media)
(measured in all replicates)
Nominal
Test Item Concentration
[mg/L] O2 -Concentration [mg/L]
Replicates
1 2 3 4
1.00 7.74 7.51 7.63 7.56
0.500 7.66 7.80 7.71 7.83
0.250 7.89 7.75 7.86 7.85
0.125 8.03 7.96 7.97 7.93
0.0625 7.95 7.88 8.01 7.92
Control 8.04 8.02 8.00 8.01
Water Parameters at 48 h (Old Media)
(measured in all replicates)
Nominal
Test Item Concentration
[mg/L] O2 -Concentration [mg/L]
Replicates
1 2 3 4
1.00 7.81 7.79 n.d. n.d.
0.500 8.10 8.09 7.96 7.93
0.250 8.07 8.00 8.15 8.17
0.125 7.94 8.20 8.13 8.12
0.0625 8.10 7.91 8.10 8.01
Control 8.02 8.17 8.13 8.10 - Salinity:
- Not measured, freshwater conditions
- Nominal and measured concentrations:
- nominal: 0.0625 - 0.125 - 0.250 - 0.500 - 1.00 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass beakers, 50 mL
- Type (delete if not applicable): closed with parafilm
- Material, size, headspace, fill volume: Glass beakers (4 cm ID x 7 cm H), 50 mL
- Aeration: No
- Renewal rate of test solution (frequency/flow rate): One application at test start, renewal after 24 h, semi-static test
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): None
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Acc. to Directive 92/69/EEC Method C.2, Annex 1
- Conductivity: Dilution water: 656 µS/cm (24 h); 656 µS/cm (48 h)
- Culture medium different from test medium: Elendt M4 acc. to ELENDT (1990), modified to a total hardness of 160 to 180 mg
CaCO3/L
- Intervals of water quality measurement: At test start and test end
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16:8 light:dark cycle
- Light intensity: Diffuse light, illumination strength max. 20 µE x m-2 x s-1
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Immobility was determined in all groups after 24 and 48 h. A daphnid was considered to be immobile if it was not able to swim within 15 sec after gentle agitation of the test vessel.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: factor 2
- Range finding study
- Test concentrations: 1 - 10 - 100 mg/L
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.53 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: (0.52 - 0.55)
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.19 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Details on results:
- -Mortality of control: 0 %
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values:The tested concentration levels were visually clear i.e. completely dissolved throughout exposure. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- EC50/LC50: 1.29 mg/L (CI 1.13 - 1.47 mg/L) - Reported statistics and error estimates:
- EC100-values after 24 and 48 h were deduced directly from the dose-response-relationships without mathematical calculation.
EC10- and EC50-values were calculated by sigmoidal dose-response regression. Calculation of the confidence intervals for EC50 were carried out using standard procedures. The concentration effect relationships are shown graphically.
Any other information on results incl. tables
Percentage of Daphnids Incapable of Swimming after 24 and 48 h of Exposure
(n = 20, divided into 4 replicates with 5 daphnids each)
Nominal |
IMMOBILIZATION [%] |
|||||||||
24 h |
48 h |
|||||||||
Replicates |
Replicates |
|||||||||
1. |
2. |
3. |
4. |
MV |
1. |
2. |
3. |
4. |
MV |
|
1.00 |
80 |
60 |
100 |
100 |
85 |
100 |
100 |
100 |
100 |
100 |
0.500 |
0 |
20 |
20 |
0 |
10 |
0 |
20 |
40 |
40 |
25 |
0.250 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.125 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.0625 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Concentrations and Recovery Rates of Praepagen HY
Sampling date |
2008-12-16 0 h new medium |
2008-12-17 24 h old medium |
2008-12-17 24 h new medium |
2008-12-18 48 h old medium |
|||||||||
Start of analysis |
2008-12-16 |
2008-12-17 |
2008-12-17 |
2008-12-18 |
|||||||||
Nominal [mg/L] |
Praepagen HY |
||||||||||||
without |
with |
without |
without daphnids |
with |
without daphnids2) |
||||||||
Meas. conc. [mg/L] |
RR [%] |
Meas. conc. [mg/L] |
RR [%] |
Meas. conc. [mg/L] |
RR [%] |
Meas. conc. [mg/L] |
RR [%] |
Meas. conc. [mg/L] |
RR [%] |
Meas. conc. [mg/L] |
RR [%] |
||
1.00* |
0.9783) |
98 |
1.00 |
100 |
1.01 |
101 |
0.990 |
99 |
0.826 |
83 |
0.860 |
86 |
|
0.500* |
0.4853) |
97 |
0.487 |
97 |
0.509 |
102 |
0.525 |
105 |
0.389 |
78 |
0.354 |
71 |
|
0.250* |
0.2423) |
97 |
0.266 |
106 |
0.264 |
106 |
0.242 |
97 |
0.197 |
79 |
0.178 |
71 |
|
0.125 |
0.1203) |
96 |
0.135 |
108 |
0.1133) |
90 |
0.125 |
100 |
0.1103) |
88 |
0.07193) |
58 |
|
0.0625 |
0.06253) |
100 |
0.0640 |
102 |
0.04533) |
72 |
0.06003) |
96 |
0.0437 |
70 |
0.04943) |
79 |
|
Control |
LOQ |
LOQ |
LOQ |
LOQ |
|||||||||
Conc.
=
Concentration
Meas. conc. =
Measured concentration of test item, mean value of 2 injections
RR = Recovery rate related to the nominal test item concentrations
LOQ = Limit of quantification
1) = Pooled samples from the test vessels per concentration level and the control
2) = Separate replicates without daphnids incubated under test conditions
3) = Repeated analysis (mean value of 2 replicates with 2 injections each)
* = Biologically relevant concentration
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The recoveries of Praepagen HY in the fresh media (at 0 and 24 hours) at the biologically relevant test concentrations 0.250 to 1.00 mg/L were in the range of 97 to 105 % of the nominal values. The recovery rates of Praepagen HY of the old media (after 24 and 48 hours) at the biologically relevant test concentrations 0.250 to 1.00 mg/L determined in pooled samples from the test vessels were in the range of 78 to 106 % of the nominal values. The additionally prepared separate replicates at the biologically relevant test concentrations 0.250 to 1.00 mg/L (prepared and incubated without daphnids) gave recoveries in the range of 71 to 106 % of the test item in the old media (after 24 and 48 hours) which were comparable to the recoveries of the old media in the test vessels with daphnids.
As the recoveries in the old media with and without daphnids were comparable and only a small decrease of the recoveries in the old media after 24 h in comparison to those in the fresh media was observed, it can be concluded that sorption of the test item to the daphnids can be neglected for this Hydroxylethylquat.
Based on these facts a correction of the nominal concentrations due to the lowered recoveries in the old media after 24 h is not justified as the test item is not sorbed in an unacceptable degree to the glass wall or the daphnids and is partly dissolved and therefore available for exposure of the daphnids in the test medium. Nominal concentrations can be used for establishing of the EC-values on immobilization. - Executive summary:
In the acute immobilization test with Daphnia magna (STRAUS) the effects of the test item Praepagen HY (batch number: DEG4036741) were determined according to OECD 202 (2004) from 2008-12-16 to 2008-12-18 at Dr.U.Noack-Laboratorien, D-31157 Sarstedt.
The study was conducted under semi-static conditions with 5 nominal test item concentrations ranging from 0.0625 to 1.00 mg/L set up in a geometric series with a dilution factor of 2 over a period of 48 hours. 20 test organisms were exposed to each test concentration and control.
Cationic surfactants are difficult to test as they exhibit different sorption mechanisms like classical van der Waals but also ionic and especially ion exchange. Cationic surfactants may sorb to negatively charged surfaces like glass and the surface of the daphnids but there is currently no mechanistic model to estimate the degree of sorption. Sorption may lead to low analytical recoveries of the test item during the test and it is therefore important to address sorption effects either to the daphnids and/or the glass surface of the test vessels.
The concentrations of Praepagen HY were determined at all concentration levels after 0 h and 24 h (fresh media) and after 24 h and 48 h (old media) via LC-MS/MS analysis. The recoveries of Praepagen HY in the fresh media (at 0 and 24 hours) at the biologically relevant test concentrations 0.250 to 1.00 mg/L were in the range of 97 to 105 % of the nominal values. The recovery rates of Praepagen HY of the old media (after 24 and 48 hours) at the biologically relevant test concentrations 0.250 to 1.00 mg/L determined in pooled samples from the test vessels were in the range of 78 to 106 % of the nominal values. The additionally prepared separate replicates at the biologically relevant test concentrations 0.250 to 1.00 mg/L (prepared and incubated without daphnia) gave recoveries in the range of 71 to 106 % of the test item in the old media (after 24 and 48 hours) which were comparable to the recoveries of the old media in the test vessels with daphnids.
As the recoveries in the old media with and without daphnids were comparable and only a small decrease of the recoveries in the old media after 24 h in comparison to those in the fresh media was observed, it can be concluded that sorption of the test item to the daphnids can be neglected for this Hydroxylethylquat.
Based on these facts a correction of the nominal concentrations due to the lowered recoveries in the old media after 24 h is not justified as the test item is not sorbed in an unacceptable degree to the glass wall or the daphnids and is partly dissolved and therefore available for exposure of the daphnids in the test medium. Nominal concentrations can be used for establishing of the EC-values on immobilization.
Water quality parameters of pH-value and dissolved oxygen concentration, measured at 0, 24 and 48 h, were determined to be within acceptable limits. The validity criteria of the test guideline were fulfilled.
EC10-, EC50- (with Confidence Interval), EC100 - Values, NOEC and LOEC
(based on the nominal concentrations of the test item Praepagen HY)
Test Duration
[h]Nominal Concentration
of the Test Item
Praepagen HY[mg/L]
Confidence Interval
p = 95%
[mg/L]EC10
24
0.500
---
48
0.468
---
EC50
24
0.737
0.663 – 0.818
48
0.534
0.521 – 0.548
EC100
24
> 1.00
---
48
1.00
---
NOEC
48
0.250
---
LOEC
48
0.500
---
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