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EC number: 946-436-3 | 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
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:
- 21 October 2016 - 12 January 2017
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aquatic toxicity testing of difficult items and mixtures, OECD series on testing and assessment number 23
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- nitrate amine salt of N-[3-dimethylaminopropyl]- C14-C20 amides, saturated, reaction products with ethylene oxide
- EC Number:
- 946-436-3
- Molecular formula:
- UVCB
- IUPAC Name:
- nitrate amine salt of N-[3-dimethylaminopropyl]- C14-C20 amides, saturated, reaction products with ethylene oxide
- Reference substance name:
- (p-chlorophenoxy)isobutyroyl chloride
- EC Number:
- 255-286-1
- EC Name:
- (p-chlorophenoxy)isobutyroyl chloride
- Cas Number:
- 41267-93-0
- Molecular formula:
- C10H10Cl2O2
- IUPAC Name:
- 2-(4-chlorophenoxy)-2-methylpropanoyl chloride
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Dihydrogen oxide
- Test material form:
- solid
- Details on test material:
- Identification: Nitrate amine salt of N-[3-dimethylaminopropyl]- C14-C20 amides, saturated, reaction products with ethylene oxide
Appearance: Light yellow lumps
Test item storage: At room temperature; Store in closed container
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- - Irritant/corrosive: yes
- Solubility in water: 5-10%
- Stability in water: stable
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Samples were taken from all test concentrations and the control according to the schedule below.
Frequency: at t=0 and t=48 h
Volume: 2.0 mL from the approximate centre of the test vessels
Storage: Samples were stored in a freezer (≤ -15°C) until analysis. Silanised vials were used to store the samples.
At the end of the exposure period, the replicates were pooled at each concentration before sampling.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION:
- Method: Direct application to test medium.
* For the range-finding test the test solution was prepared at a loading rate of 100 mg/L and stirred for three days. The dispersion was filtered through a 0.45 μm membrane filter (Whatman, RC55) to remove any undissolved material. The resulting saturated solution was used as the highest test concentration and lower test concentrations were prepared by dilution of this saturated solution in test medium. All final test solutions were clear and colourless. A slight layer of foam was observed in the two highest concentrations.
* For the final test the test solution was prepared at 1.0 mg/L applying 15 minutes of stirring, which resulted in a clear and colourless solution that was used as the highest test concentration. Lower test concentrations were prepared by dilution of the highest test concentration in test medium. The glassware used in the final test was incubated with test concentrations 24 hours prior to the start of the test to improve the stability of the exposure concentrations, as the test item tends to adsorb to glass. The solutions used for incubation were discharged before the start of the test and the daphnids were exposed to freshly prepared solutions.
- Controls: test medium without test item or other additives (blank-control)
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain: Straus, 1820
- Source: in-house laboratory culture with a known history. At least third generation, obtained by a cyclical parthenogenesis under specified breeding conditions.
- Age of parental stock: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
- Age at study initiation: < 24 hours, from parental daphnids of more than two weeks old.
- Feeding during test: no
ACCLIMATION
- Acclimation period: no
BREEDING:
- Method: each batch was started with newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 5 litres of medium (M7) in an all-glass culture vessel. After 7 days of cultivation half of the medium was renewed twice a week.
- Feeding: daily, a suspension of fresh water algae.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 180 mg CaCO3/L
- Test temperature:
- 19-20 °C
- pH:
- 7.8-8.0
- Dissolved oxygen:
- 8.9-9.0 mg O2/L
- Nominal and measured concentrations:
- Nominal test concentrations: 0.022, 0.046, 0.1, 0.22, 0.46 and 1.0 mg/L
Average exposure concentrations (t=0-48 h): 0.0083, 0.018, 0.053, 0.13, 0.28 and 0.66 mg/L, respectively corresponding to nominal concentrations above.
Measured concentrations were 72-80% of nominal at the start of the test and had decreased to 23-69% of initial at the end of the test, therefore final results were based on the geometric mean measured concentrations. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 ml, all-glass
- Fill volume: 80 mL, pre-incubated with test concentrations for 24 hours
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Standard medium used: yes, adjusted ISO medium
- Source/preparation of dilution water: tap water purified by reverse osmosis
- Culture medium different from test medium: yes, M7 was used as culture medium
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours, daily
EFFECT PARAMETERS MEASURED: mobility at 24 and 48 hours.
- Additional measurements: pH and dissolved oxygen at the beginning, after 24 hours of exposure and at the end of the test, for all concentrations and the control. Temperature of the medium: continuously in a temperature control vessel.
RANGE-FINDING STUDY
- Test concentrations: 0.10, 1.0, 10 and 100% of a saturated solution prepared at 100 mg/L
- Results used to determine the conditions for the definitive study: yes, the EC50 was expected to be between 0.1% and 10% of a saturated solution prepared at 100 mg/L. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (November 2016)
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.115 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CI 0.098-0.133 mg/L
- Details on results:
- - No biological, behavioural or other abnormalities were observed in the control group or any of the test concentrations.
- One daphnia was observed trapped at the surface after 24 hours at the average exposure concentration of 0.28 mg/L (this daphnia was reimmersed into the respective solutions before recording of mobility).
- Because the test solutions did not remain stable over the 48 h period (23-69% of initial measured concentrations), the final results were based on geometric mean measured concentrations (t=0-48 h).
- Individual pH, temperature and dissolved oxygen values remained within acceptable limits throughout the duration of the study. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- 48h-EC50: 0.58 mg/L, 95%-confidence interval: 0.49-0.67 mg/L
- Other: results fell within the historical range. - Reported statistics and error estimates:
- The EC50-values were calculated from the weibits of the percentages affected daphnids and the logarithms of the corresponding test item geometric mean measured concentrations using the maximum likelihood estimation method.
ToxRat Professional v 3.2.1 (ToxRat Solutions® GmbH, Germany) was used to perform the analyses.
Any other information on results incl. tables
In the range-finding test, no daphnids became immobilized in the control or in the lowest concentration tested throughout the test duration. In the higher test concentrations, effects were complete after 24 hours of exposure. Microscopic observations of daphnids exposed to 1.0% of the saturated solution at prepared at 100 mg/L revealed no test item attached to their bodies at 24 hours of exposure.
Table 1 Average exposure concentration versus nominal concentration
Test item1 Nominal concentration (mg/L) |
Measured concentrations (mg/L) |
Average exposure (mg/L) |
|
t=0h |
t=48h |
||
0.022 |
0.017 |
0.0040 |
0.0083 |
0.046 |
0.033 |
0.0097 |
0.018 |
0.1 |
0.077 |
0.036 |
0.053 |
0.22 |
0.17 |
0.094 |
0.13 |
0.46 |
0.35 |
0.23 |
0.28 |
1 |
0.80 |
0.55 |
0.66 |
1 Nitrate amine salt of N-[3-dimethylaminopropyl]- C14-C20 amides, saturated, reaction products with ethylene oxide.
Table 2 Number of introduced daphnids and incidence of immobility in the final test
Time (h) |
Replicate |
|
Test item1, Average exposure concentration (mg/L) |
|||||
Control |
0.0083 |
0.018 |
0.053 |
0.13 |
0.28 |
0.66 |
||
0 |
A |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
B |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
C |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
D |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
Total introduced |
20 |
20 |
20 |
20 |
20 |
20 |
20 |
|
|
||||||||
24 |
A |
0 |
0 |
0 |
0 |
1 |
5 |
5 |
B |
0 |
0 |
0 |
0 |
0 |
5 |
5 |
|
C |
0 |
0 |
0 |
0 |
3 |
5(1) |
5 |
|
D |
0 |
0 |
0 |
0 |
2 |
4 |
5 |
|
Total immobilized |
0 |
0 |
0 |
0 |
6 |
19 |
20 |
|
Effect % |
0 |
0 |
0 |
0 |
30 |
95 |
100 |
|
|
|
|
|
|
|
|
||
48 |
A |
0 |
0 |
0 |
0 |
3 |
5 |
5 |
B |
0 |
0 |
0 |
0 |
3 |
5 |
5 |
|
C |
0 |
0 |
0 |
0 |
4 |
5 |
5 |
|
D |
0 |
0 |
0 |
0 |
4 |
5 |
5 |
|
Total immobilized |
0 |
0 |
0 |
0 |
14 |
20 |
20 |
|
Effect % |
0 |
0 |
0 |
0 |
70 |
100 |
100 |
1 Nitrate amine salt of N-[3-dimethylaminopropyl]- C14-C20 amides, saturated, reaction products with ethylene oxide
( ) between brackets: number of daphnia observed trapped at the surface of the test solutions. These organisms were reimmersed into the respective solutions before recording of mobility.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- 1). In the control, no daphnids became immobilised or showed other signs of disease or stress. 2). The oxygen concentration at the end of the test was ≥ 3 mg/L in control and test vessels.
- Conclusions:
- The 48h-EC50 of Nitrate amine salt of N-[3-dimethylaminopropyl]- C14-C20 amides, saturated, reaction products with ethylene oxide, towards Daphnia magna, was 0.115 mg/L based on geometric mean measured concentrations.
- Executive summary:
In a 48 h acute toxicity study conducted according to OECD guideline 202 and GLP principles, water fleas (Daphnia magna) were exposed to the test substance under static conditions at the following nominal concentrations: 0 (blank-control), 0.022, 0.046, 0.1, 0.22, 0.46 and 1.0 mg/L. Exposure concentrations were varified by a validated analytical method to be 0, 0.0083, 0.018, 0.053, 0.13, 0.28 and 0.66 mg/L. Measured concentrations were 72 -80% of nominal at the start of the test and decreased to 23 -69% of initial at the end of the test. The incidence of immobilisation was recorded at 24 and 48 hours.
The 48h-EC50 was 0.115 mg/L based on geometric mean measured concentrations. The acceptability criteria were met and the study is considered to be reliable with no restrictions.
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