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EC number: 836-530-1 | CAS number: 1296134-40-1
- 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:
- Aug 28 - Dec 11, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study was conducted for a registration in non-EU.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- Council Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and the council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
A preparation with a test item concentration of 100 mg/L was freshly prepared.
For that purpose, the test item was weighed in a calibrated flask and vehicle was added. The preparation was stirred with a magnetic stirrer for 24 hours. Then the formulation was passed through a filter membrane (pore size: 0.2 µm). The filtrate was used for the study. The pH was not adjusted. - Analytical monitoring:
- no
- Remarks:
- The test item concentration was not quantified at the start and the end of this study. Because of the low water solubility of a comparable chemical, the compound cannot be detected with standard analytical methods.
- Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A preparation with a test item concentration of 100 mg/L was freshly prepared.
For that purpose, the test item was weighed in a calibrated flask and vehicle was added. The preparation was stirred with a magnetic stirrer for 24 hours. Then the formulation was passed through a filter membrane (pore size: 0.2 µm). The filtrate was used for the study. The pH was not adjusted.
- Controls: reconstituted water
- Chemical name of vehicle: OECD 203 Medium - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish (Danio rerio)
- Strain: West-Aquarium
- Source: Institute of Toxicology, Merck KGaA
- Age at study initiation (mean and range, SD):
- Length at study initiation: 2.7-2.9 cm
- Weight at study initiation:: 0.2 -0.4 g (control group) and 0.2 -0.4 g (test material group)
ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation:
- Feeding frequency during acclimation: During the acclimatization, until one day before the experimental part, the fish were fed with flakes (Tetra Min® diet; Tetra GmbH, Melle). Furthermore, the fish were fed with daphnia, or artemia, or frozen mosquitolarva daily.
- Health during acclimation (any mortality observed): no mortality observed
FEEDING DURING TEST
The zebrafish were not fed during the study. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- no
- Hardness:
- about 228 mg/L CaCO3
- Test temperature:
- 23 to 24°C
- pH:
- 7.49-7.95
- Dissolved oxygen:
- 75.6 - 93.3%
- Salinity:
- no data
- Conductivity:
- 710 µS/cm (vehicle)
- Nominal and measured concentrations:
- Nominal Concentration: 100 mg/L
- Details on test conditions:
TEST SYSTEM
- Test vessel: 10L glass aquarium
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass, 10L, no headspace, about 10L
- Aeration: none
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 10
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water (OECD 203 Medium)
- Ca/Mg ratio: 4 : 1
- Culture medium different from test medium: no
- Intervals of water quality measurement: daily
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12 hours light - 12 hours dark regime
- Light intensity: no data
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality and Clinical Symptoms (daily)
TEST CONCENTRATIONS
- Range finding study:
- Test concentrations: 0 mg/L and 100 mg/L (nominal)
- Results used to determine the conditions for the definitive study: no mortality observed- Reference substance (positive control):
- no
- Duration:
- 24 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: > 1.6281 × 10-6 mg/L
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: > 1.6281 × 10-6 mg/L
- Duration:
- 72 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: > 1.6281 × 10-6 mg/L
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: > 1.6281 × 10-6 mg/L
- Details on results:
- A saturated aqueous solution of the test material of nominal 100 mg/L revealed no aquatic toxicity in the test system. The 96 h LC50 value to zebrafish exceeded the maximal solubility of 1.6281 × 10-6 mg/L of the test material in reconstituted water and, thus, could not be determined in this test.
The 96h EC50 exceeded the water solubility of 1.6281 × 10-6 mg/L (nominal >100 mg/L) and, thus, could not be determined in this study.
- Behavioural abnormalities: no
- Observations on body length and weight: none
- Other biological observations: none
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: yes - Validity criteria fulfilled:
- yes
- Conclusions:
- A saturated aqueous solution of the test material of nominal 100 mg/L revealed no aquatic toxicity in the test system. The 96 h LC50 value to zebrafish exceeded the maximal solubility of 1.6281 × 10-6 mg/L of the test material in reconstituted water and, thus, could not be determined in this test.
- Executive summary:
Objective
The objective of this study was to determine the acute toxicity of the test material in the zebrafish (Daniorerio).
Study design
For this purpose, 10 fish (test material group) and further 10 fish (control group) were exposed over 96 hours, under defined conditions in a limit test. The fish were observed for signs of toxicity or death for 96 hours.Zebra fish of the test material groupwere exposed to a saturated aqueous test material solution of nominal 100 mg/L (limit test) in an open static system.
Results
The zebrafishexposed to an aqueous solution, with a nominal concentration of 100 mg/L were not affected.
The test material concentration in the aqueous medium was not quantified at the start and the end of this study due to the low water solubility (1.6281 × 10 -6 mg/L). The water solubility was determined for a structurally related chemical, within the scope of another study. Because of the low water solubility, the compound cannot be detected with standard analytical methods. The development of an analytical method with a sufficiently low detection and quantification limit is complex. Due to the absence of any adverse effects at the saturation concentration, the study was performed without analytical concentration verification.
For the test material, the following LC50values forzebrafishwere determined.
24 h LC50 nominal > 100 mg/L(>1.6281 × 10-6 mg/L)
48 h LC50 nominal > 100 mg/L(>1.6281 × 10-6 mg/L)
72 h LC50 nominal > 100 mg/L(>1.6281 × 10-6 mg/L)
96 h LC50 nominal > 100 mg/L (> 01.6281 × 10-6 mg/L)
Conclusion
A saturated aqueous solution of the test material of nominal 100 mg/L revealed no aquatic toxicity in the test system. The 96 h LC50 value to zebrafish exceeded the maximal solubility of 1.6281 × 10-6 mg/L of the test material in reconstituted water and, thus, could not be determined in this test.
Reference
Description of key information
OECD 203: EC50 (96 h) > 100 mg/L (nominal); no adverse effects were seen up to the limit of water solubility (1.6281 × 10-6 mg/L)
Key value for chemical safety assessment
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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