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EC number: 800-036-4 | CAS number: 1422423-64-0
- 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:
- March from 7th to 18th, 2016
- 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:
- adopted 17th July, 1992
- 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:
- The test item concentrations were determined at the beginning of the test and after 2, 24, 48, 72 and 96 h of exposure.
- Vehicle:
- no
- Details on test solutions:
- Since the test item is soluble, the test solution was prepared by directly dissolving the test item in natural water.
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish.
- Source: Aquarium Stern, 4310 Rheinfelden.
- Length at study initiation: length of 1–3 cm
ACCLIMATION
- Acclimation period: the fish were gradually acclimatized for at least an additional 12 days prior to testing.
- Acclimation conditions: the fish were gradually acclimatized to the test conditions and were held in water of similar temperature (23 ± 2.0 °C) and quality used in the test.
- Culture conditions: 16 h a day; 21–25 °C, controlled by a thermostat at ± 2 °C; medium Continuously aerated natural water of the town of Schlieren.
QUARANTINE
- Duration: young fish are held under quarantine conditions in 40 l glass aquaria until use in the test. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Test temperature:
- Control: 21.5 - 22 °C
Test vessel: 21.5 - 22 °C
Controlled by a thermostat at ± 2 °C - pH:
- Control: 6.8 - 8.3
Test vessel: 6.5 - 8.3 - Dissolved oxygen:
- Control: 6.9 - 8.0 mg/l
Test vessel: 7.0 - 8.4 mg/l - Nominal and measured concentrations:
- 100 mg/l nominal concentration.
- Details on test conditions:
- A fine-mesh dip net was used to transfer fish, taking care to minimise possible stress due to handling. The transfer was performed in an impartial manner to eliminate bias (as regards weight and length of the fish). No fish were damaged or dropped during the transfer.
TEST SYSTEM
- Test vessel: glass aquaria filled with 1.0 liter of water.
- Aeration: continuously aerated natural water of the town of Schlieren.
- Renewal rate of test solution: fresh test solutions were prepared after 24, 48 and 72 h, into which the fish were transferred after each 24 h exposure period.
- No. of organisms per vessel: 7 fish per test concentration and control.
- No. of vessels per concentration: 1 replicate.
- No. of vessels per control: 1 replicate. Natural water, without addition of any kind of additive, was used for the blank control.
- Biomass loading rate: total loading ≤ 1 g fish weight/l.
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: natural water supplying the laboratory.
- pH: 7.4 - 7.8
- Electric conductivity (room temperature): 477 - 536 μS/cm
- Total Hardness: 20.6 - 24.2 °f H; 2.06 - 2.42 mmol/l; 206 - 242 mg/l
- CO3 Hardness: 18.6 - 21.7 °f H; 186 - 217 mg/l
- Residual Hardness: 2.0 - 3.0 °f H; 20 - 30 mg/l
- Acid consumption: 3.72 - 4.34 mmol/l
- Colony counts (30°C): 0 - 1 per ml
- Escherichia coli: 0 per 100 ml
- Enterococcus: 0 per 100 ml
- Nitrate: 7.3 mg/l
- Chloride: 16.1 mg/l
- Sulfate: 18.6 mg/l
OTHER TEST CONDITIONS
- Adjustment of pH: yes, the pH was adjusted to pH 6.5 - 7.0.
- Photoperiod: 16 h photoperiod a day, supplied by overhead white fluorescent tubes, no transition period.
TEST CONCENTRATIONS and SYSTEM
- Justification for concentration choice: the concentration was chosen based on preceding studies tests with Alga and Daphnia, where the 72 h ErC50 value for Alga and the 48 h-EC50 value for Daphnia were >100 mg/l nominal concentration (information provided by the sponsor).
- Justification for test system choice: because the test item proved to be readily biodegradable (ca. 96.9 % biodegradation within one week; information provided by the sponsor), semi-static exposure conditions were applied.
EFFECT MEASURED
Fish are considered to be dead if they show no reaction after touching the caudal fin and there is no visible movement (e.g. gill movements).
The median lethal concentration (LC50 value) is the concentration killing 50 % of the fish after a certain period of exposure.
PARAMETERS MEASURED
- Oxygen, pH, temperature: measurements were made prior to the addition of the fish to the test solutions and after 2h of exposure as well as in the old and fresh test solutions after each 24 h period until the end of the test.
- Behaviour and mortality: observations of any potential abnormal behaviour of the fish were made after 2, 24, 48, 72 and 96 h of exposure. Mortality of the fish was recorded at the same time intervals. Any dead fish were removed immediately from the test media, and their respective weight and length were recorded.
- Fish length and weight: at the end of the test, length and weight of all surviving fish were also recorded. - Reference substance (positive control):
- no
- 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: 99% CL
- Details on results:
- The no-observed-effect concentration (NOEC) was 100 mg/l nominal concentration.
At the nominal concentration of 100 mg/l test item, none of a total of seven fish died after 96 h of exposure. No mortality was observed in the blank control.
Toxic effects other than mortality, such as loss of coordination, hypo- or hyperactivity and swimming on the back, were not observed.
TEST CONCENTRATIONS
The test concentration could satisfactorily be maintained over the 96 h test period. Since all measurements were within the 80-120 % range of the nominal concentration, the assessment of the toxicity was based on the nominal concentrations. - Sublethal observations / clinical signs:
Concentrations of test item, measured by HPLC (mg/l)
Nominal concentration (mg/l) 0 h 2 h 24 h 48 h 72 h 96 h old new old new old new 100 101 101 102 99.4 103 101 103 100 104 Data of surviving fish at the end of the exposure (96 h)
Nominal concentration (mg/l) Length (mm) and weight (mg) of the individual fish Total fish loading (g/l medium)* Blank control Length 12 14 12 11 11 13 12 - Weight 16 25 15 12 9 17 16 0.11 100 Length 11 10 14 14 14 14 11 - Weight 15 9 30 23 32 24 13 0.15 * maximal total loading recommended by OECD TG 203: 1 g fish per liter medium
All fish were within the recommended size range of 1-3 cm.
- Validity criteria fulfilled:
- yes
- Conclusions:
- LD59 (96h) > 100 mg/l (nominal)
- Executive summary:
Method
The acute lethal toxicity of test substance to Danio rerio (Zebrafish) was investigated under semi-static exposure conditions over a period of 96 h, according to the OECD Guideline 203.
The only applied nominal concentration was 100 mg/l. Therefore, this study represents a limit test. This concentration was chosen based on preceding studies tests with Alga and Daphnia, where the 72 h ErC50value for Alga and the 48 h-EC50value for Daphnia were >100 mg/l nominal concentration.
Since the test item proved to be readily biodegradable, semi-static exposure conditions were applied. Since the test item is highly soluble, the test solution was prepared by directly dissolving the test item in natural water.
The concentrations of test item were measured by HPLC at the beginning of the test and after 2, 24, 48, 72 and 96 h of exposure, in old and fresh medium. These analyses showed that the test concentration could satisfactorily be maintained over the whole 96 h exposure period. Since all measurements were within the 80-120 % range of the nominal concentration, the assessment of the toxicity was based on the nominal concentrations.
Observations
At the nominal concentration of 100 mg/l of test substance, none of a total of seven fish died after 96 h of exposure. No mortality was also observed in the blank control.
Toxic effects other than mortality, such as loss of coordination, hypo- or hyperactivity and swimming on the back, were not observed.
The no-observed-effect concentration (NOEC) was 100 mg/l nominal concentration.
Results
Based on the binominal theory, the absence of mortality in such a test design provides at least 99 % confidence that the median lethal concentration (LC50) of substance to Danio rerio (Zebrafish) is greater than the applied nominal concentration of 100 mg/l.
Reference
Description of key information
LD50 (96h) > 100 mg/l (nominal)
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 100 mg/L
Additional information
The acute lethal toxicity of test substance to Danio rerio (Zebrafish) was investigated under semi-static exposure conditions over a period of 96 h, according to the OECD Guideline 203 by means of a limit test (100 mg/l, nominal).
The concentration of test item was measured by HPLC at the beginning of the test and after 2, 24, 48, 72 and 96 h of exposure, in old and fresh medium. These analyses showed that the test concentration could satisfactorily be maintained over the 96 h test period. Since all measurements were within the 80-120 % range of the nominal concentration, the assessment of the toxicity was based on the nominal concentrations.
At the nominal concentration of 100 mg/l of test substance, after 96 hours, no deaths occurred. Toxic effects other than mortality, such as loss of coordination, hypo- or hyperactivity and swimming on the back, were not observed.
The NOEC can be considered as equal/higher than 100 mg/l (nominal); the LC50 resulted greater than the applied nominal concentration of 100 mg/l.
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