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EC number: 221-361-2 | CAS number: 3077-27-8
- 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 fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Nov - 27 Nov 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- yes
- Remarks:
- For further information see section "Any other information on material and methods incl tables".
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht Rheinland-Pfalz, Mainz, Germany
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Control and test item concentration
- Sampling method: Concentration was measured at the beginning and at the end of the test and on at medium renewal after 24 h in the new and the old solutions.
- Sample storage conditions before analysis: Samples were frozen - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Differential loading: A saturated solution was prepared for the test. This was done by weighing the nominal load of 100 mg/L, adding the corresponding amount of tap water and shaking vigorously for 24 h. The resulting solution was filtrated through 0.45 μm cellulose ester filters. On each day of the experiment, the necessary solutions were freshly prepared.
- Controls: Yes, medium only - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Source: Dehner Garten Center, Neustadt, Germany (date of arrival 05 Jul 2018)
- Length at study initiation: 2 ± 1 cm
- Method of breeding: Vessels: polyethylene aquaria; Medium: tap water; Feeding: two times a day with warmwater fishfood, totalling about 1-2% of body weight per day; Photoperiod 12/12 h; Temperature 23 ± 2 °C
ACCLIMATION
- Acclimation period: at least 12 days
- Acclimation conditions: same as test conditions
- Type and amount of food during acclimation: warmwater fishfood , totalling about 1 - 2% of body weight per day
- Feeding frequency during acclimation: three times a day
- Health during acclimation: mortality was observed after day 7 (3 of 18 animals were found dead -corresponding to 16.7%)
FEEDING DURING TEST: no feeding during the test; 24 h before the start of the test, the test fish were no longer fed. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 0.88 (medium) mmol/L
- Test temperature:
- 23.1 – 24.0 °C (deviation within on test 1 °C)
- pH:
- 7.8 - 7.9 (Control)
7.7 - 7.9 (100 mg/L) - Dissolved oxygen:
- 8.3 - 9.1 mg/L (Control)
8.2 - 9.1 mg/L (100 mg/L) - Conductivity:
- 210 µS/cm at 25 °C (tap water)
- Nominal and measured concentrations:
- nominal: Control and 100 mg/L
The measured concentrations are listed in section "Any other information on results incl tables" in table 4-5 - Details on test conditions:
- TEST SYSTEM
Test vessel:
- Type: Open
- Material, size, headspace, fill volume: glass, 10 L, headspace: 3 L, fill volume: 7 L
- Aeration: Accomplished with glass tubes
- Renewal rate of test solution: every 24 hours
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates):1
- Biomass loading rate: 1 fish/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap/Drinking water see analysis in table 1 in section "Any other information on material and methods incl tabels"
- Culture medium different from test medium: No
OTHER TEST CONDITIONS
- Photoperiod: 12/12 hours using neon tubes
EFFECT PARAMETERS MEASURED: Mortality was recorded every 24 h
TEST CONCENTRATIONS
- Range finding study : No pre-test was performed - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 32.23 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 32.23 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Mortality of control: No mortality was observed
- Other biological observations: The toxicity against Danio rerio was tested using a semi-static test design. The study was performed as a limit test using the concentration 100 mg/L (nominal). In the treatment and the control, no mortality was observed. - Sublethal observations / clinical signs:
Biological Results:
Table 1: pH-Values
Nominal Concentration in mg/L
pH at t in h (old/new test solution)
0 h
24 h
48 h
72 h
96 h
new
old
new
old
new
old
new
old
Blank control
7.8
7.8
7.8
7.8
7.9
7.8
7.8
7.8
100
7.7
7.8
7.8
7.9
7.9
7.8
7.8
7.8
Table 2: O2 Values
Nominal Concentration in mg/L
O2 in mg/L at t in h (old/new test solution)
0 h
24 h
48 h
72 h
96 h
new
old
new
old
new
old
new
old
Blank control
9.1
8.7
8.6
8.5
9.0
8.7
9.0
8.3
100
8.9
8.6
8.6
8.4
9.1
8.6
9.0
8.2
Tabel 3: Temperature
Nominal Concentration in mg/L
Temperature in °C (old/new test solution)
0 h
24 h
48 h
72 h
96 h
new
old
new
old
new
old
new
old
Blank control
24.0
23.3
23.4
23.1
23.3
23.2
23.1
23.2
100
23.3
23.1
23.3
23.2
23.3
23.4
23.2
23.3
Table 4: Measured Concentrations
Nominal
Conc.Test Item
Measured
Conc.
t = 0 hMeasured
Conc.
t = 24 h
old solution
Measured
Conc.
t = 24 h
new solution
Measured
Conc.
t = 48 h
old solution
Measured
Conc.
t = 48 h
new solution
mg/L
µg/L
µg/L
µg/L
µg/L
µg/L
Blank control
n. m.
--
--
--
--
100
n. m.
22.19
103.15
80.94
30.04
n. m. = not measured because of a technical defect of the originally planned LC-MS-MS
Table 5: Measured Concentrations, continuance
Nominal
Conc.Test Item
Measured
Conc.
t = 72 h
old solution
Measured
Conc.
t = 72 h
new solution
Measured
Conc.
t = 96 h
old solution
Geometric Mean
Measured
Conc.
additional new
solution
mg/L
µg/L
µg/L
µg/L
µg/L
µg/L
Blank control
--
--
n. d.
--
--
100
12.26
16.44
0.64*
32.23
94.83
*Implausible low measured concentration, an error in sampling was suspected, value excluded from evaluation.
n. d. = not detectable
Analytical Results:
At each measurement the recovery of the QC samples was taken into account because the recovery was not in the range of 97% - 103% of the nominal value. At the beginning the measurement was not yet stable. This can be seen from the area values of the QC sample. Deviating from the study plan, the recovery of QC samples was taken into account although the recovery was not in the range of 97% - 103% of the nominal value. This can be stated as uncritical because it was clear to see that the measurement stabilized later and an additional later measurement was therefore not necessary.
The measured concentration in the freshly prepared solutions was between 16.44 μg/L and 103.15 μg/L and in the old solutions between 0.64 μg/L and 80.94 μg/L. A sampling error is assumed as reason of the implausible low measured concentration of 0.64 μg/L at the end of the test. This value was excluded from evaluation. Reason for the scattering measured concentrations in the test solutions might be the presence of the fish and their excrements.
Table 6: Validity criteria
Criterion from the guideline
Outcome
Validity criterion fulfilled
The mortality in the control(s) should not exceed 10% (or one fish if less than ten are used) at the end of the test
No mortality was observed
Yes
The dissolved oxygen concentration must have been at least 60 per cent of the air
saturation value throughout the test
92%
Yes
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
Reference
Description of key information
LC50 (96h) >32.23 µg/L (Danio rerio, OECD 203, measured geometric mean)
Key value for chemical safety assessment
Additional information
One experimental study is available investigating the toxicity of 4-(octadecylamino)-4-oxoisocrotonic acid (CAS 3077-27-8) to fish. The study was conducted according to OECD 203 (GLP) using the zebrafish Danio rerio as test species (LAUS GmbH, 2018c) under semi-static conditions with daily medium renewal. A nominal test item concentration of 100 mg/L was tested in a limit test. The test solution was prepared by adding appropriate amounts of test item to test medium, followed by intensive stirring and filtration. During the study the actual concentrations in the test medium was measured by HPLC/MS. The measured concentration in the freshly prepared solutions was between 16.44 μg/L and 103.15 μg/L and in the aged test solutions between 0.64 μg/L and 80.94 μg/L, respectively. Therefore the results are given based on the geometric mean of the measured concentrations. Hence the LC50 (96 h) was determined to be > 100 mg/L (nominal) and > 32.23 μg/L (geom. mean measured concentration). The measured water solubility for the test item was determined to be 5.9 mg/L at 25 °C, pH 5. The discrepancy between the low recovery in the test solutions and the water solubility may have been caused by the different test media, pH-values and temperature.
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