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EC number: 224-167-6 | CAS number: 4221-98-1
- 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:
- 2017-09-24 to 2017-09-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: 10 mL of the test item concentration and the control were filled into a vial.
- Sample storage conditions before analysis: All samples were stored at 6 +- 2 °C until sample preparation and at room temperature until the start of the analysis, if necessary. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A saturated solution with a nominal loading of 5.00 mg/L test item which corresponds to 5.97 µL/L of the test item was prepared with dilution water one day prior to the start of exposure in two glass flasks with screw caps (each 5000 mL). These dispersions were stirred for 24 hours with 1100 rpm at room temperature. After a separation phase of 1 hour, the saturated solution was removed by siphoning (from the approximate bottom of the flasks) and used in the test. The solution was checked after stirring via laser beam (Tyndall effect) for undissolved test item (formation of an emulsion). The Tyndall effect was negative.
- Controls: Blank control with dilution water
- Evidence of undissolved material: No (Tyndall effect was negative, see above) - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish
- Source: Gained at Noack Laboratorien GmbH from a single brood stock (supplier: Umweltbundesamt, Schichauweg 58, D-12307 Berlin)
- Length at study initiation: 2.59 cm
- Weight at study initiation: 0.11 g
ACCLIMATION
- Acclimation period: 12 days
- Type and amount of food during acclimation: Sera Vipan, Sera GmbH, 52518 Heinsberg, Germany; 4% of the fish body weight per feeding day
- Feeding frequency during acclimation: 3 times per week; not fed 24 h before test start
- Health during acclimation: No mortality observed
FEEDING DURING TEST: No - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 64 mg/L as CaCO3 (day 0, limit concentration and control)
- Test temperature:
- 22.3 - 23.1 °C (mean: 22.7 °C)
- pH:
- 7.19 - 7.50
- Dissolved oxygen:
- 96 - 100 % saturation (new medium), 83 - 90 % saturation (old medium)
- Conductivity:
- 138 µS/cm
- Nominal and measured concentrations:
- Nominal loading rate: 5 mg/L
Measured (geometric mean): 590 µg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: Aquaria
- Material, size, headspace, fill volume: Glass, 13 L nominal volume, filled with approximately 8 L of dilution water (dimensions 25.5/18/28 cm, depth of water: 20 cm), covered with a floating lid
- Aeration: No aeration was provided
- Renewal rate of test solution: Daily
- No. of organisms per vessel: 7
- No. of vessels per concentration: 1
- No. of vessels per control: 1
- Biomass loading rate: 0.0963 g fish per liter test solution
- Introduction of fish: Randomly
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water; filtered on activated charcoal and aerated for at least 24 hours to remove chlorine. Nominal water parameters:
Total hardness: 64 mg CaCO3/L
pH-value: 6.0 - 8.5
Acidity: 0.1 mmol/L
Alcalinity: 0.6 mmol/L
Conductivity: 138 µS/cm
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light, 8 hours darkness
- Light intensity: 7 - 750 Lux
EFFECT PARAMETERS MEASURED : Mortality (animals were considered dead if there was no visible movement and if touching of the caudal peduncle produced no reaction); sublethal effects, observations were made after 3, 24, 48, 72 and 96 hours
TEST CONCENTRATIONS
- Range finding study: Not performed. - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 0.59 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- > 0.59 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- 0.59 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Mortality of control: No
- Other adverse effects control: No
- Abnormal responses: No
- Any observations that might cause a difference between measured and nominal values: No
- Effect concentrations exceeding solubility of substance in test medium: No
VALIDITY OF THE TEST
- O2 saturation => 83%
- No mortality in control
- Deviation of pH value in control group over test duration: 0.31 units
- Measured concentrations of the test item in the range of 67 - 81% of the initially measured concetrations at the end of the test
The test is considered to be valid.
- Results with reference substance (positive control):
- Positive control was not performed
- Reported statistics and error estimates:
- LC50 values do not have to be calculated in a limit test.
- Sublethal observations / clinical signs:
Table 1: Measured concentrations and percent of the initial concentrations of the test item
Sampling date 0 hours
(Fresh medium)24 hours
(Old medium)24 (hours
(Fresh medium)48 hours
(Old medium)48 hours
(Fresh medium)Nominal loading of the test item [mg/L] Meas. conc. [µg/L] Meas. conc. [µg/L] % Meas. conc. [µg/L] Meas. conc. [µg/L] % Meas. conc. [µg/L] 5 718 478 67 591 477 81 689 Control < LOQ < LOQ < LOQ < LOQ < LOQ Sampling date 72 hours
(Old medium)72 (hours
(Fresh medium)96 hours
(Old medium)Geometric mean measured concentration [µg/L] Nominal loading of the test item [mg/L] Meas. conc. [µg/L] % Meas. conc. [µg/L] Meas. conc. [µg/L] % 5 484 70 779 584 75 590 Control < LOQ < LOQ < LOQ < LOQ Table 2: Observations of sub lethal effects and normal behavior in the test vessels
Geometric mean measured concentration of the test item [µg/L] Effect Number of fish effected at abservation time [hours] 3 24 48 72 96 590 (1) 0 0 0 0 0 Control (1) 0 0 0 0 0 (1) = Normal behaviour
Table 3: Cumulative mortality [%] in the test vessels
Geometric mean measured concentration of the test item [µg/L] Cumulative mortality [%]
after different exposure periods [hours]3 24 48 72 96 590 0 0 0 0 0 Control 0 0 0 0 0 - Validity criteria fulfilled:
- yes
- Conclusions:
- The 96h LC50 of the test item was determined to be > 0.59 mg/L (based on geometric mean measured concentration).
- Executive summary:
To assess the toxicity to fish, a GLP-compliant acute toxicity test according to OECD Guideline 203 and EU Method C.1 was conducted under semi-static conditions with daily renewal of the test media. Fish (Danio rerio) were exposed to the limit loading of 5.00 mg/L (corresponding to a geometric mean measured concentration of 590 µg test item/L) over a test duration of 96 hours. Seven test organisms were exposed to the threshold loading and the control along with a negative control. The concentrations of the test item were analytically verified via GC-MS at the start (0, 24, 48, 72 h) and at the end (24, 48, 72, 96 h) of the exosure intervals in the tested concentration level and the control. The measured concentrations of the test item at the end of each exposure interval were in the range of 67 to 81% of the initially measured concentrations. All effect values given are based on the geometric mean measured test item concentration of the test item. In result, the 96 h LC50 of the test item was determined to be > 0.59 mg/L. All validity criteria of the test guidelines were met.
Reference
Description of key information
The 96h LC50 of the substance was determined to be > 0.59 mg/L (based on geometric mean measured concentrations).
Key value for chemical safety assessment
Additional information
To assess the toxicity to fish, a GLP-compliant acute toxicity test according to OECD Guideline 203 and EU Method C.1 was conducted under semi-static conditions with daily renewal of the test media. Fish (Danio rerio) were exposed to the limit loading of 5.00 mg/L (corresponding to a geometric mean measured concentration of 590 µg test item/L) over a test duration of 96 hours. Seven test organisms were exposed to the threshold loading and the negative control (without the test item). The concentrations of the test item were analytically verified via GC-MS at the start (0, 24, 48, 72 h) and at the end (24, 48, 72, 96 h) of the exosure intervals in the tested concentration level and the control. The measured concentrations of the test item at the end of each exposure interval were in the range of 67 to 81% of the initially measured concentrations. All effect values given are based on the geometric mean measured test item concentration of the test item. In result, the 96-h LC50 of the test item was determined to be > 0.59 mg/L. All validity criteria of the test guidelines were met.
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