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Diss Factsheets
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EC number: 288-293-3 | CAS number: 85711-34-8
- 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:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- July 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Duplicate samples were taken from the single loading rate and the control at the start and at the end of the first and last of the four 24-hour test medium renewal periods.
All samples were stored deep-frozen (at about -20 °C) immediately after sampling. - Vehicle:
- no
- Details on test solutions:
- A water accommodated fraction (WAF) with a loading rate of 5.0 mg/L was prepared. Prior to the start of the test and prior to the start of the test medium renewals, the test medium was prepared by weighing nominal 25 mg of the test item into 5000 mL test water (ISO 6341, half-concentrated). Ultrasonic treatment for 15 minutes was applied and thereafter, the dispersions were stirred for 48 hours at room temperature in the dark. The stirring period of 48 hours was considered reasonable to achieve maximum solubility for the different components of the test item.
Then, the dispersion was filtered through membrane filters (Whatman, Type NC45, pore size 0.45 µm). The filters were pre-conditioned with 300 mL filtrate. The undiluted filtrate was tested as WAF.
The method of preparation of the test media was based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000.
- Controls: test water (ISO 6341, half-concentrated) - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Source: Breeding culture at the testing laboratory
- Length at study initiation(length definition, mean, range and SD): measured from the mouth to the end of the tail fin, 2.2 ± 0.07 cm
- Weight at study initiation (mean and range, SD): 0.13 ± 0.01 g
- Feeding during test: none
HOLDING AND ACCLIMATION
No medication was applied during holding and acclimatization.
- Acclimation period: ≥ 1 week
- Acclimation conditions (same as test or not): same
- Feeding during acclimation: until one day before the start of the test, the fish were fed with a commercial fish diet (Tetra Min® Hauptfutter, TETRA-Werke, 49324 Melle / Germany)
- Health during acclimation (any mortality observed): During the last four weeks prior to the test, no fish died in the test fish batch and all fish were healthy.
FEEDING DURING TEST
none - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 1.25 mM (125 mg CaCO3/L)
- Test temperature:
- 21 - 22 °C
- pH:
- 6.9 - 7.7
- Dissolved oxygen:
- ≥ 7.5 mg/L (≥ 83 % oxygen saturation)
- Nominal and measured concentrations:
- nominal loading rate: 5.0 mg/L as WAF
measured test concentrations: below the limit of quantification (LOQ) of 1 mg/L in all samples.
The biological results are based on the loading rate of the test item. - Details on test conditions:
- TEST SYSTEM
- Test vessel: full glass aquarium, containing five liters test medium
- Type (delete if not applicable): open
- Aeration: none
- Renewal rate of test solution (frequency/flow rate): after 24 hours
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.25 g fish wet weight/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: purified water
- Alkalinity: 0.4 mM
- Ca/Mg ratio: 4:1
- Culture medium different from test medium: no
- Intervals of water quality measurement: water temperature, pH values and oxygen concentrations were measured for each treatment at the start of the test and once daily during the test in the freshly prepared and aged test medium. At the same dates the appearance of the test medium was recorded.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hour light to 8-hour dark photoperiod, with a 30-minute transition period
- Light intensity 13 – 18 µE s-1 m-2
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality and sub-lethal effects; recorded at approx. 2, 24, 48, 72 and 96 hours
TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable (limit test/threshold approach)
- Results used to determine the conditions for the definitive study: A limit test based on the threshold approach was performed (OECD Series on testing and assessment No. 126 (2010): Short Guidance on the Threshold Approach for Acute Fish Toxicity). The selected loading rate of 5.0 mg/L corresponded approximately to the lower EL50 value determined in an algae study (OECD 201, EC C.3) and an acute daphnia study (OECD 202, EC C.2). The lower EL50 value was determined in the algae test to be 4.8 mg/L, based on growth rate (EL50 for daphnia was 57 mg/L). - Reference substance (positive control):
- not required
- Key result
- Duration:
- 96 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- nominal loading rates
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other:
- Remarks:
- highest concentration tested in a threshold approach
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- nominal loading rates
- Basis for effect:
- other: mortality and sub-lethal effects
- Remarks on result:
- other:
- Remarks:
- highest concentration tested in a threshold approach
- Details on results:
- - Behavioural abnormalities:
- Other biological observations: none; all fish survived and no visible abnormalities were observed.
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Effect concentrations exceeding solubility of substance in test medium: Yes; the solubility of the test item in test water was below the LOQ of the analytical method (< 1 mg/L).
The test medium was a clear solution throughout the test medium renewal periods of 24 hours. - Reported statistics and error estimates:
- The NOELR and LL0 were determined directly from the raw data. The LOELR, LL100 and LL50 at the observation times could not be quantified due to the absence of a toxic effect of the test item at the tested loading rate.
- Validity criteria fulfilled:
- yes
- Remarks:
- / mortality of control animals <10 %; concentration of dissolved oxygen in all test vessels >60 % saturation
Reference
Description of key information
effect value for Danio rerio, based on loading rates (OECD 203, EU C.1; threshold approach):
96-h LL50: > 5.0 mg/L (solubility in test water < 1 mg/L)
Key value for chemical safety assessment
Additional information
LL50 for freshwater fish: > 5.0 mg/L (threshold approach).
The results indicate that the test material is not toxic to fish up to the limits of its solubility (< 1 mg/L in test water) and a NOEC and thus a PNEC cannot be determined.
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