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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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- REG (EC) No. 440/2008, May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: nominal 100, 50, 25, 12.5, 6.25 mg/L as WAF and control
- Sampling intervals: start and end of the first and the last renewal period
- Sampling method: samples were taken from test vessels containing fish
- Sample storage conditions before analysis: samples taken at the start of the first and last renewal period were stored for one day after processing (freeze-drying) - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: water accommodated fractions (WAFs)
Supersaturated solutions were prepared by dispersing/dissolving the test item into the test medium (filtered tap water) at nominal concentrations of 100, 50, 25, 12.5 and 6.25 mg/L. These dispersions were shaken for about 24 hours at approximately 30°C and then equilibrated for about 24 hours at the test temperature. The resulting dispersions were opalescent. The non-dissolved test material was removed by filtration through a 0.22-µm filter to provide the WAFs. The filtrates were clear and transparent. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish
- Source: “Black Molly” Fish Farm, Veszprém, Hungary (for the pre-tests) and Ágnes Németh (for definitive test), Veszprém, Hungary
- Length at study initiation (mean and range, SD): 3.0 ± 0.14 cm (2.7-3.3 cm, n= 42)
- Weight at study initiation (mean and range, SD): 0.38 ± 0.03 g (0.34-0.41 g, n= 42)
- Feeding during test: none
ACCLIMATION
- Acclimation period: > 12 days
- Acclimation conditions (same as test or not): same water quality (circulated and filtered tap water)
- Type and amount of food: commercial fish food (TetraMin staple food for ornamental fish, Tetra GmbH, Germany) at 2-10 mL per feeding.
- Feeding frequency: three times per week, until 24 hours before the start of the test
- Health during acclimation (any mortality observed): The fish were healthy. There was no mortality of the population for seven days before the test - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 203 mg/L as CaCO3 (measured)
- Test temperature:
- 21.1-22.0 °C
- pH:
- 7.08-7.52
- Dissolved oxygen:
- 82-98% air saturation value
- Nominal and measured concentrations:
- nominal loading rates: 100, 50, 25, 12.5, and 6.25 mg/L as WAF
first renewal period (0-24 h):
- freshly prepared test media: 3.99, 3.13, 2.38, 1.57, and 0.11 mg/L
- aged test media (24 h): 1.36, 1.41, 0.47, 0.25 mg/L, and < LOQ (0.08 mg/L).
second renewal period (72-96 h; the two highest loading rates (100 and 50 mg/L) were not analysed since all fish were dead at that time):
- freshly prepared test media: 2.10, 1.13, and 0.30 mg/L
- aged test media (24 h): 0.18, 0.14 mg/L, and < LOQ (0.08 mg/L).
geometric mean measured concentrations: 2.33, 2.10, 0.81, 0.50, mg/L and 0.09 mg/L.
biological results are based on the nominal loading rates. - Details on test conditions:
- TEST SYSTEM
- Test vessel: aquaria, containing 5 litres of medium
- Type: not reported (the test material is not volatile)
- Aeration: not reported (oxygen concentration was sufficient during exposure)
- Renewal rate of test solution: daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.48 - 0.57 g body weight/L (mean 0.53 ± 0.03 g bw/L)
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: circulated and filtered tap water
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light, 8 hours dark
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality and sub-lethal effects; recorded at approx. 3, 6, 24, 48, 72 and 96 hours
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.0
- Range finding study
- Test concentrations: nominal 100, 10, 1, and 0.1 mg/L
- Results used to determine the conditions for the definitive study: 100% and 25% mortality after 96 hours at 100 and 10 mg/L respectively; no mortality at the lower test concentrations - Reference substance (positive control):
- not required
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- 28 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% confidence limits: 19-41 mg/L; results are expressed in terms of loading rate
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 6.25 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: results are expressed in terms of loading rate
- Duration:
- 96 h
- Dose descriptor:
- LOELR
- Effect conc.:
- 12.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: one dead fish after 96 h; results are expressed in terms of loading rate
- Duration:
- 96 h
- Dose descriptor:
- LL0
- Effect conc.:
- 6.25 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: results are expressed in terms of loading rate
- Duration:
- 96 h
- Dose descriptor:
- LL100
- Effect conc.:
- 50 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: results are expressed in terms of loading rate
- Details on results:
- - Behavioural abnormalities: at the 72-hour observation, one fish showed swimming problems at the nominal loading rate of 25 mg/L; no abnormalities observed at any other concentration and/or time
- Mortality of control: zero
- Other adverse effects control: none
For cumulative mortality data Table 1. - Reported statistics and error estimates:
- The 24, 48, 72 and 96 hours LL50 values were calculated by Probit analysis with 95% confidence limits using SPSS PC+ software.
The NOELR, LOELR, LL0 and LL100 were determined directly from the raw data. - Sublethal observations / clinical signs:
Table 1: Cumulative mortality data:
Nominal loading rate (mg/L)
Cumulative mortality [number dead of fish] *
3 h
6 h
24 h
48 h
72 h
96 h
Control
0
0
0
0
0
0
6.25
0
0
0
0
0
0
12.5
0
0
0
0
0
1
25
0
0
0
0
0**
1
50
0
0
0
6
7
-
100
0
0
1
7
-
-
*: initial population = 7 fish
**: one fish with swimming problems
- Validity criteria fulfilled:
- yes
- Remarks:
- no mortality of control animals; concentration of dissolved oxygen in all test vessels >60% saturation
- Conclusions:
- The test material is toxic to freshwater fish with a 96-hour LL50 between 10 and 100 mg/L (calculated value: 28 mg/L).
Reference
Description of key information
96-h LC50 (based on nominal loading rates) 28 mg/L for Brachydanio rerio (new name Danio rerio) (OECD 203, EU C.1)
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 28 mg/L
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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