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EC number: 291-768-8 | CAS number: 90480-35-6
- 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:
- 2017-08-25 to 2017-08-29
- 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:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 4.31 mg/L
- Sampling method: The limit loading level and the control were analytically verified from all freshly prepared and aged test media.
- Sample storage conditions before analysis: All samples were stored at 6 ± 2 °C until sample preparation and at room temperature until the start of the analysis (on an autosampler), - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Preparatoin as a WAF, water accomodated fraction.
- Method: An appropriate volume of the test item was introduced in the 2000 mL dilution water by pipette in brown glass flasks. The dispersions were shaken for 24 hours with 20 rpm at room temperature. After completion of shaking and following a separation phase of at least 1 hour of standing, the aqueous phase or WAF was removed from the approximate center of the water body by siphoning.
- Controls: 7 fish in dilution water (without test item) were tested under the same test conditions as the test replicate.
- Chemical name of vehicle: dilution water
- Test concentration: 4.31 mg/L - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Strain: Danio rerio
- Source: a single brood stock
ACCLIMATION
- Acclimation period: at least 12 days
- Acclimation conditions: same as test
- Type and amount of food during acclimation: Sera Vipan, 4 % of the fish body weight per feeding day.
- Feeding frequency during acclimation: 3 times per week, not fed 24 h before the test start - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 57 mg/L as CaCO3
- Test temperature:
- 22.7-23.4°C
- pH:
- pH at the start of exposure: 7.47-7.60 (4.31 mg/L), 7.32-7.69 (control)
pH at the end of exposure: 7.24-7.32 (4.31 mg/L), 7.17-7.36 (control) - Dissolved oxygen:
- 9.97 mg/L
- Nominal and measured concentrations:
- Nominal: 4.31 mg/L
Measured: 3.23-3.66 mg/L (fresh medium) - Details on test conditions:
- TEST SYSTEM
- Test vessel: 13 L glass aquaria
- Type: closed, covered with a floating lid
- Material, size, headspace, fill volume: Glass aquaria of 13 L, filled with approximately 8 L of dilution water
- Aeration: No aeration
- Renewal rate of test solution (frequency/flow rate): 24 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): One replicate
- No. of vessels per vehicle control (replicates): One replicate
- Biomass loading rate: 0.15 g fish per litre test solution
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water of local origin
- Chlorine:filtered on activated charcoal and aerated for at least 24 h to remove chlorine.
- Total hardness: 10 - 250 mg CaC03/L
- pH-value: 6.0 - 8.5
- Acidity: 0.1 mmol/L
- Alcalinity: 0.6 mmol/L
- Conductivity: 138 µS/cm
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light / 8 h dark
- Light intensity: 7 - 750 Lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Biological Parameters: observed for visible abnormalities after 3, 24, 48, 72 and 96 h. Measured size and weight of the control fish at the end of the exposure.
- Physical Properties: The pH-value, temperature and oxygen saturation were measured in all test vessels at test start and end and every 24 hours and after renewal of the test media from fresh and old test media. Total hardness was determined at the start of the exposure out of the control. Water temperature was recorded once per hour during the test. Light intensity was measured at the start of the exposure.
TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: Based on the toxicity data of the test item of an acute immobilization test to Daphnia magna (EL50(0-48h) = 4.31 mg/L) and an algae toxicity test (ErL50 (0-72 h) = 6.90 mg/L, EyL50(0 - 72 h)= 4.57 mg/L, based on nominal loading levels of the water accommodated fractions of the test item), a limit test is justified.
- Test concentrations: 4.31 mg/L was tested as a threshold loading level in a limit test - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 4.31 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LL0
- Effect conc.:
- >= 4.31 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LL100
- Effect conc.:
- > 4.31 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Biological Data: No mortality occurred.
- Physicochemical data: The environmental conditions (pH-value, temperature and oxygen-saturation) were determined to be within the acceptable limits. Light intensity was measured at the start of the exposure and ranged from 46 to 62 (mean value 55) Lux. The test solution showed slight turbidity during the period of exposure
- Analytical data: The measured concentrations of the two main constituents of the test item at the end of each exposure interval were in the range of 68 to 75% of the initially measured concentrations. - Sublethal observations / clinical signs:
Biological results:
Nominal loading level of the test item
[mg/L]
Effect
Number of fish effected at observation time [hours]
3
24
48
72
96
4.31
Quiescence
7
7
7
7
7
Control
Normal behaviour
7
7
7
7
7
Cumulative Mortality [%]:
Nominal loading level of the test item [mg/L]
Cumulative mortality [%] after different exposure periods [hours]
3
24
48
72
96
4.31
0
0
0
0
0
Control
0
0
0
0
0
Analytical results:
Measured concentrations of the two main constituents and percent of the initial concentrations:
Sampling date
0 hours
(Fresh medium)
24 hours
(Old medium)
24 hours
(Fresh medium)
48 hours
(Old medium)
Nominal concentration
of the test item [mg/L]
Meas. conc.
[mg/L]
Meas.conc.
[mg/L]
%
Meas. conc.
[mg/L]
Meas.conc.
[mg/L]
%
4.31
3.44
2.47
72
3.66
2.48
68
Control
< LOQ
< LOQ
< LOQ
< LOQ
Sampling date
48 hours
(Fresh medium)
72 hours
(Old medium)
72 hours
(Fresh medium)
96 hours
(Old medium)
Nominal concentration
of the test item [mg/L]
Meas. conc.
[mg/L]
Meas.conc. [mg/L]
%
Meas. conc.
[mg/L]
Meas.conc.
[mg/L]
%
4.31
3.23
2.41
75
3.61
2.63
73
Control
< LOQ
< LOQ
< LOO
< LOQ
- Validity criteria fulfilled:
- yes
- Conclusions:
- The threshold loading of the test item was found to have no lethal effects on zebrafish when tested with the water accommodated fraction with the nominal loading of 4.31 mg/L. In conclusion, the LL0 corresponds to the nominal loading of ≥ 4.31 mg test item/L. The LL50 and LL100 correspond to the nominal loading of > 4.31 mg test item/L.
- Executive summary:
The acute toxicity of the test item to fish (zebrafish) was determined according to the OECD Guideline for Testing of Chemicals No. 203 (1992) and EU Council Regulation No. 440/2008/C.1 (2008), in a semi-static limit test in a closed system without headspace with a threshold concentration of 4.31 mg/L. Exposure was assessed for 96 hours. 7 test organisms were exposed each for the test concentration and the control. The water quality parameters pH-value, temperature and oxygen saturation, measured after 0, 24, 48, 72 and 96 h, were determined to be within the acceptable limits.
The concentration of the test item was analytically verified via GC-MS from all freshly prepared media and aged test media during exposure. The measured concentrations of the two main constituents of the test item at the end of each exposure interval were in the range of 68 to 75% of the initially measured concentrations. This means, that the test item was stable during the exposure. All effect values given are based on the nominal test item loading.
The threshold loading of the test item was found to have no lethal effects on zebrafish when tested with the water accommodated fraction with the nominal loading of 4.31 mg/L. In conclusion, the LL0 corresponds to the nominal loading of >= 4.31 mg test item/L. The LL50 and LL100 correspond to the nominal loading of > 4.31 mg test item/L.
Reference
Description of key information
One study is available for this endpoint in which the toxicity to fish was assessed according to OECD 203 and EU Method C.1, in a semi-static limit test in a closed system without headspace. The LL0 corresponds to the nominal loading of ≥ 4.31 mg test item/L. The LL50 and LL100 correspond to the nominal loading of > 4.31 mg test item/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 4.31 mg/L
Additional information
For this endpoint only one test is available. In this acute toxicity test with fish (Danio rerio or zebrafish), the effects of a threshold concentration of 4.31 mg/L of the test item were determined according to OECD 203 (1992).
7 test organisms were exposed each for the test concentration and the control. The water quality parameters pH-value, temperature and oxygen saturation, measured after 0, 24, 48, 72 and 96 h, were determined to be within the acceptable limits.
The concentration of the test item was analytically verified via GC-MS from all freshly prepared media and aged test media during exposure. The measured concentrations of the two main constituents of the test item at the end of each exposure interval were in the range of 68 to 75% of the initially measured concentrations. This means, that the test item was sufficiently stable during the exposure. All effect values given are based on the nominal test item loading.
All validity criteria of the test guideline were met.
The threshold loading of the test item was found to have no lethal effects on zebrafish when tested with the water accommodated fraction with the nominal loading of 4.31 mg/L. In conclusion, the LL0 corresponds to the nominal loading of ≥ 4.31 mg test item/L. The LL50 and LL100 correspond to the nominal loading of > 4.31 mg test item/L.
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