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EC number: - | 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 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:
- 2021-02-24 - 2021-06-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Also conducted according to GLP, and designed according to OECD GD 23.
- Justification for type of information:
- See attached justification.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- June 18 2019
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Series on testing and assessment, No.23 “Guidance document on aqueous phase aquatic toxicity testing of difficult test chemicals”,
- Version / remarks:
- February 2019
- Qualifier:
- according to guideline
- Guideline:
- ISO 7346/1-3 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)])
- Version / remarks:
- 1996
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2021-03-17
- Analytical monitoring:
- yes
- Details on sampling:
- Samples were taken from the control and all test solutions at the start and every 24h thereafter in old and new solutions.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: an excess of the test item was added to 10 L of water. The mixing vessel was closed and mixing was initiated with the vortex extending ca. 10% of the vessel depth. The solution was mixed for 24 hours in the dark at room temperature and then left 1h undisturbed before use.
- Test concentration separation factor: 1.5
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): The test solutions were observed to be clear. The Tyndall effect was verified and not observed.
- Other relevant information: The concentration of the stock solution was analytically verified and the required dilutions for the test concentrations were determined from this confirmed concentration. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish
- Source: Elevage de la grande rivière, le Fond Garel, 69490 Saint Forgeux, France
- Age at study initiation (mean and range, SD): Juveniles
- Length at study initiation (length definition, mean, range and SD): average 1.86 cm
- Weight at study initiation (mean and range, SD): average 0.130 g
ACCLIMATION
- Acclimation period: 9 days
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food during acclimation: flaked, powdered or live food (such as brine shrimp nauplii)
- Feeding frequency during acclimation: Daily until 24 hours before the start of the test
- Health during acclimation (any mortality observed): No mortality observed in the 7d period prior the start of the test
FEEDING DURING TEST: No feeding during test - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 40 - 250 mg/L (as CaCO3)
- Test temperature:
- 22.1 - 23.6 °C
- pH:
- Start: 8.00 - 8.31
End: 7.54 - 7.79 - Dissolved oxygen:
- Start: 96.6% - 97.8%
End: 83.0% - 90.2% - Conductivity:
- < 10 µS.cm-1
- Nominal and measured concentrations:
- Nominal: 1.5, 2.2, 3.3, 5.0, and 7.5 mg.L-1
Geometric means of the analytically confirmed concentrations: 1.41, 1.95, 3.09, 4.76 and 6.59 mg.L-1 - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass vessels
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 3.5 L capacity filled with minimum headspace (ca. 1 cm)
- Aeration: None
- Renewal rate of test solution (frequency): daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: < 0.8 g.L-1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water as described in OECD TG 203
- TOC < 0.3 mg.L-1
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16h light : 8h dark
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Fish were inspected 1 and 4 hours after the start of the exposure, and every day twice a day thereafter until the end of the test.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.5
- Range finding study
- Test concentrations: 1.0, 2.5, 5.0 and 8.0 mg.L-1
- Results used to determine the conditions for the definitive study: After 96h 0% mortality at <= 2.5 mg.L-1; 100% mortality at >= 5.0 mg.L-1 - Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 3.785 mg/L
- 95% CI:
- 2.925 - 4.842
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Details on results:
- No mortality was observed in the control at the end of the test.
The dissolved oxygen concentration was higher than 60% of the air saturation value throughout the test in all vessels.
Since concentrations of the test substance were not maintained on the first day within 80% of the nominal concentrations, results were based on the geometric of the analytically confirmed concentrations. - Sublethal observations / clinical signs:
Table. Incidence of mortality and total mortality during the final test
Nominal concentration mg.L-1
(Geometric mean of measured concentration mg.L-1)Control
(0)1.50
(1.41)2.20
(1.95)3.30
(3.09)5.00
(4.76)7.50
(6.59)Dead fish Surviving fish with sublethal effects or abnormalities Mortality (%) Dead fish Surviving fish with sublethal effects or abnormalities Mortality (%) Dead fish Surviving fish with sublethal effects or abnormalities Mortality (%) Dead fish Surviving fish with sublethal effects or abnormalities Mortality (%) Dead fish Surviving fish with sublethal effects or abnormalities Mortality (%) Dead fish Surviving fish with sublethal effects or abnormalities Mortality (%) 1h 0 0 - 0 0 - 0 0 - 0 2 - 0 7 - 0 7 - 4h 0 0 - 0 0 - 0 0 - 0 3 - 0 5 - 0 7 - 24h 0 0 0 0 0 0 0 7 0 0 7 0 0 7 0 2 5 28.6 48h 0 0 0 0 0 0 0 7 0 0 7 0 1 6 14.3 7 0 100 72h 0 0 0 0 0 0 0 7 0 2 5 28.6 3 4 42.9 7 0 100 96h 0 0 0 0 0 0 0 7 0 3 4 42.9 4 3 57.1 7 0 100 Types of sublethal effects/abnormalities observed: abnormal swimming behavior, lighter skin pigmentation, loss of equilibrium, irregular ventilation, hypo/hyperactivity.
Table. Concentrations of the test item (mg.L-1) in test water
Nominal concentration (mg.L-1) Measured concentration (mg.L-1) Geometric mean analytically confirmed concentrations Start (0h) 24h (old) 24h (new) 48h (old) 48h (new) 72h (old) 72h (new) 96h (end) mg.L-1 %Nominal Control < LOD < LOD < LOD < LOD < LOD < LOD < LOD < LOD N/A N/A 1.5 1.53 1.32 1.52 1.25 1.59 1.20 1.62 1.31 1.41 94 2.2 2.04 1.51 2.25 1.81 2.37 1.78 2.20 1.80 1.95 89 3.3 3.24 2.37 3.47 2.79 3.89 2.92 2.91 3.37 3.09 94 5.0 4.46 3.89 5.90 4.33 5.88 4.42 4.79 4.76 4.76 95 7.5 7.31 5.22 7.15 6.91 - - - - 6.59 88 Analysis were not performed after 48h at the highest concentration as all fish were dead.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The toxicity of the test item to the zebrafish (Danio rerio) was investigated in a closed semi-static test. Under the experimental conditions and based upon analytically confirmed concentrations, the 96-hour LC50 value was 3.785 mg.L-1.
- Executive summary:
The toxicity of the test item to Danio rerio was investigated in a study conducted according to the OECD TG 203 (2019) and in compliance with GLP. The design further included the recommendations of the OECD GD 23 (testing difficult substances).
Following a preliminary range-finding study, seven fish were exposed to an aqueous solution of the test item over 96 hours at the required nominal test concentrations 1.5, 2.2, 3.3, 5.0 and 7.5 mg.L-1, and to a control. The mortality of the fish was determined by visual observation after 1, 4, 24, 48, 72 and 96 hours. Samples taken from the control and all test concentrations were analysed at the start of the test and every 24 hours thereafter in old and new solutions with surviving fish.
The analytical results of this test showed that test item levels were overall maintained within 80% of the nominal concentrations throughout the duration of the test, except for the first day of the test where measured concentrations were slightly lower than 80%. Therefore, the evaluation of the effects on Danio rerio was based on the geometric of the analytically confirmed concentrations: 1.41, 1.95, 3.09, 4.76 and 6.59 mg.L-1. After the 96-hours exposure, mortality was 0% at 1.41 and 1.95 mg.L-1, 42.9% at 3.09 mg.L-1, 57.1% at 4.76 mg.L-1 and 100% at 6.59 mg.L-1.
Under experimental conditions and based upon analytically confirmed concentrations, the 96-hour LC50 value was 3.785 mg.L-1.
Reference
Description of key information
The toxicicity of the test item to the zebrafish (Danio rerio) was investigated in a closed semistatic test. Under experimental conditions and based upon analytically confirmed concentrations, the 96-hour LC50 value was 3.785 mg.L-1.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- EC50
- Effect concentration:
- 3.785 mg/L
Additional information
The toxicity of the test item to Danio rerio was investigated in a study conducted according to the OECD TG 203 (2019) and in compliance with GLP. The design further included the recommendations of the OECD GD 23 (testing difficult substances).
Following a preliminary range-finding study, seven fish were exposed to an aqueous solution of the test item over 96 hours at the required nominal test concentrations 1.5, 2.2, 3.3, 5.0 and 7.5 mg.L-1, and to a control. The mortality of the fish was determined by visual observation after 1, 4, 24, 48, 72 and 96 hours. Samples taken from the control and all test concentrations were analysed at the start of the test and every 24 hours thereafter in old and new solutions with surviving fish.
The analytical results of this test showed that test item levels were overall maintained within 80% of the nominal concentrations throughout the duration of the test, except for the first day of the test where measured concentrations were slightly lower than 80%. Therefore, the evaluation of the effects on Danio rerio was based on the geometric of the analytically confirmed concentrations: 1.41, 1.95, 3.09, 4.76 and 6.59 mg.L-1. After the 96-hours exposure, mortality was 0% at 1.41 and 1.95 mg.L-1, 42.9% at 3.09 mg.L-1, 57.1% at 4.76 mg.L-1 and 100% at 6.59 mg.L-1.
Under experimental conditions and based upon analytically confirmed concentrations, the 96-hour LC50 value was 3.785 mg.L-1.
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