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EC number: 247-196-6 | CAS number: 25707-70-4
- 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
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2022-02-08 to 2022-02-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- April 13, 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
- Version / remarks:
- October 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- May 30, 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Chemical Name: N,N’-Bis(1,3-dimethylbutylidene)ethylenediamine
- CAS No.: 25707-70-4
- EC No.: 247-196-6 - Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: samples were taken from each testing concentration and from the control at
the start and at the end of each water renewal period
- Sample storage conditions before analysis: no - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: mechanical dispersion of about 1 hour to obtain a clear solution without using of any solubilising agent; test solutions of subsequent lower concentrations were prepared by appropriate diluting of this stock solution
- Controls: negative control, positive control
- Test concentration separation factor: 2.1
- Evidence of undissolved material: no - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Age at study initiation: less than 24 hours old at the start of the exposure period
- Stage at study initiation: juvenile
- Method of breeding: bred in laboratory
- Source: Laboratory of Hydrobiology (Central Agricultural Office, Directorate of Plant-, and Soil Protection) 2100 Gödöllő, Kotlán S. u. 3. Hungary
- Feeding during test: no
ACCLIMATION
- Acclimation period: at least 48 hours prior to the start of the test
- Acclimation conditions: same as test
- Type and amount of food: daphnids were fed with concentrated algal suspension of
Raphidocelis subcapitata during the holding
- Health during acclimation: apparently healthy animals - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- Post expossure observation not performed
- Hardness:
- The mean hardness of test water was determined to be 42.7 mg/L (as CaCO3) using “VISCOLOR® HE kit total Hardness H 20 F” reagent set (Lot: 0988, Exp. date: 31 May 2022). Due to the chemical properties of the used test medium (OECD medium) the measured values were out of the recommended range of 140 – 250 mg/L, however this deviation was considered to be acceptable and does not affect the results of the test.
- Test temperature:
- The test temperature was in the range of 19.6 – 20.4°C measured in the test vessels during the test.
- pH:
- The test was carried out without adjustment of pH. The pH did not vary by more than 1.5 units within the test vessels during the exposure. Measured values of pH was in the range of 6.83 – 8.92 during the test.
- Dissolved oxygen:
- The dissolved oxygen concentration was in the range of 8.07 – 8.64 mg/L during the test.
- Salinity:
- not applicable
- Nominal and measured concentrations:
- nominal: 5.14, 10.8, 22.7, 47.6 and 100 mg/L; measured: 1.05, 2.64, 4.02 and 26.09 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass beakers
- Material, size, headspace, fill volume: Glass beakers of 50 mL volume filled up with approx. 40 mL test medium.
- Renewal rate of test solution (frequency/flow rate): renewal of the test solution after 24 h
- 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): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Based on the results of preliminary solubility test, the test item could not be completely dissolved at a concentration level of 100 mg/L in ISO medium, therefore OECD medium (reconstituted water, according to OECD 201) was used as dilution water (and for holding the daphnia during acclimatization) in the experiment (in which the test item could be diluted completely at 100 mg/L). This approach has been used previously and showed to have no effect on the daphnia growth. Test animals showed no sign of any stress during acclimatisation or testing in OECD medium.
OTHER TEST CONDITIONS
- Adjustment of pH: The test was carried out without adjustment of pH. The pH did not vary by more than 1.5 units within the test vessels during the exposure.
- Photoperiod: The light-dark cycle during the test was 16 hours light (artificial illumination) and 8 hours darkness.
- Light intensity: Light intensity was measured at the start of the experiment and determined as 540 lux.
EFFECT PARAMETERS MEASURED :
The immobility or mortality of the Daphnia was determined by visual observation after 24 and 48 hours of exposure. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker were considered to be immobile. In addition to immobility, behaviour or appearance was also observed. The behaviour of the test item in test medium was observed daily and any occurred phenomena (e.g.: precipitation, adsorption) recorded.
RANGE-FINDING STUDY
- Test concentrations: 0, 1, 10, 100 mg/L
- Results used to determine the conditions for the definitive study: After 48 h, 0 animals of the 1 mg/L test concentration and 3 and 10 of the10 and 100 mg/L test group, respectively, were found to be immobilized. - Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 2.64 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.05 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 2.15 mg/L
- 95% CI:
- >= 1.66 - <= 2.52
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 1.44 mg/L
- 95% CI:
- >= 0.84 - <= 1.81
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Immobilisation of control: After 48-h exposure no immobilisation was observed in the control.
- Any observations that might cause a difference between measured and nominal values: No precipitation or any abnormal appearance of test solutions was observed during the test. - Validity criteria fulfilled:
- yes
- Conclusions:
- In the 48-hour acute toxicity test on Daphnia magna, the obtained results showed that the test item had toxic effects on the mobility of Daphnia. The 48-h EC50 value was determined to be 2.15 mg/L. The 48-h NOEC was determined to be 1.05 mg/L. The results are based on measured test item concentrations.
- Executive summary:
The acute toxicity of the test item was investigated in a 48-h immobilization test with Daphnia magna. The study was conducted according to OECD Guideline No. 202 and in compliance with GLP. Young Daphnia were exposed in a semi-static immobilisation test to aqueous test media containing the test item for 48 hours. The test media renewal period was 24 h. Based on the results of a preliminary experiment, nominal concentrations of 5.14, 10.8, 22.7, 47.6 and 100 mg/L were investigated in the main study. The corresponding calculated exposure concentrations (based on analytical measurements) were the following: 1.05, 2.64, 4.02, 9.86 and 26.09 mg/L. The immobility or mortality of the Daphnia was determined by visual observation after 24 and 48 hours of exposure. Concentrations were determined using GC-MS method. All validity criteria were met and therefore the study was considered to be valid. As a result, the 48-h EC50 value was determined to be 2.15 mg/L. The 48-h NOEC was determined to be 1.05 mg/L.
Reference
Table 1: Immobilisation of the test animals (summary)
Concentration[mg/L] | Number of Daphnia | Number of immobilised | % of immobilised | |||
nominal | exposure | 24 h | 48 h | 24 h | 48 h | |
Control | – | 20 | 0 | 0 | 0 | 0 |
5.14 | 1.05 | 20 | 0 | 0 | 0 | 0 |
10.8 | 2.64 | 20 | 5 | 16 | 25 | 80 |
22.7 | 4.02 | 20 | 6 | 19 | 30 | 95 |
47.6 | 9.97 | 20 | 12 | 20 | 60 | 100 |
100 | 26.26 | 20 | 15 | 20 | 75 | 100 |
Table 2: Summary of Biological Endpoints (based on the measured concentrations (i.e. calculated exposure concentrations)
Endpoints | Concentration [mg/L] |
48 h-EC10 | 1.44 |
95 % conf. limits | 0.84 – 1.81 |
48 h-EC20 | 1.65 |
95 % conf. limits | 1.07 – 2.01 |
48 h-EC50 | 2.15 |
95 % conf. limits | 1.66 – 2.52 |
48 h-NOEC | 1.05 |
48 h-LOEC | 2.64.2 |
Validity of the test:
– The immobilisation rate of the introduced Daphnia did not exceed 10 % in the control. No immobility was observed and no Daphnia were trapped at the water surface or showed any sign of stress.
– The dissolved oxygen concentration at the end of the test was more than 3 mg/L in control and test vessels. All validity criteria were met, therefore the study is considered to be fully valid.
Description of key information
In the 48-hour acute toxicity test with Daphnia magna, the obtained results showed that the test item had toxic effects on the mobility of Daphnia. The 48-h EC50 value was determined to be 2.15 mg/L. The 48-h NOEC was determined to be 1.05 mg/L.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- EC50
- Effect concentration:
- 2.15 mg/L
Additional information
The acute toxicity of the test item was investigated in a 48-h immobilization test with Daphnia magna. The study was conducted according to OECD Guideline No. 202 and in compliance with GLP. Young Daphnia were exposed in a semi-static immobilisation test to aqueous test media containing the test item for 48 hours. The test media renewal period was 24 h. Based on the results of a preliminary experiment, nominal concentrations of 5.14, 10.8, 22.7, 47.6 and 100 mg/L were investigated in the main study. The corresponding calculated exposure concentrations (based on analytical measurements) were the following: 1.05, 2.64, 4.02, 9.86 and 26.09 mg/L. The immobility or mortality of the Daphnia was determined by visual observation after 24 and 48 hours of exposure. Concentrations were determined using GC-MS method. All validity criteria were met and therefore the study was considered to be valid. As a result, the 48-h EC50 value was determined to be 2.15 mg/L. The 48-h NOEC was determined to be 1.05 mg/L.
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