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EC number: 235-552-3 | CAS number: 12284-76-3
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- 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:
- Water samples were taken from the control and 100 mg/L loading rate WAF test vessel at 0, 24, 48 and 72 hours from fresh media and at 24, 48, 72 and 96 hours from old media for quantitative analysis. The samples were stored frozen prior to analysis.
A set of duplicate samples at 0 and 72 hours (fresh media) and 24 and 96 hours (old media) was taken and stored frozen for further analysis if necessary. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
Due to the low aqueous solubility and complex nature of the test item, for the purposes of the study the test medium was prepared as a WAF of the test item. A nominal amount of test item (2200 mg) was added to the surface of 22 liters of test water to give the 100 mg/L loading rate. After the addition of the test item, the test water was stirred by magnetic stirrer using a stirring rate such that a vortex was formed to give a dimple at the water surface. The stirring was stopped after 23 hours and the mixture allowed to stand for 1 hour. Microscopic observations made on the WAF indicated that a significant amount of dispersed test item was present in the water column and hence it was considered justifiable to remove the insoluble test substance by filtering through a glass wool plug (2 to 4 cm in length). A wide bore glass tube, covered at one end with Nescofilm was submerged into the vessel, sealed end down, to a depth of approximately 5 cm from the bottom of the vessel. A length of Tygon tubing was inserted into the glass tube and pushed through the Nescofilm seal. A glass wool plug was inserted into the opposite end of the tubing and the WAF removed by mid-depth siphoning (the first 75 to 100 mL discarded) to give the 100 mg/L loading rate WAF. Microscopic observations of the WAF were performed after filtering through glass wool plug showed microdispersions present, therefore the WAF was filtered through filter paper. Following filtration through filter paper, no microdispersions were observed. - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: Rainbow trout
- Strain: N/A
- Source: Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK
- Age at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD): 4.3 cm (SD = 0.41)
- Weight at study initiation (mean and range, SD): 0.69 g (SD = 0.17)
- Method of breeding: NA supplied as juvenniles
- Maintenance of the brood fish: NA
ACCLIMATION
- Acclimation period: At least one week
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food during acclimation:Commercial trout pellets
- Feeding frequency during acclimation:
- Health during acclimation (any mortality observed): Zero mortality in the 7 day period prior to the start of test
FEEDING DURING TEST
- Animals were not fed during the test in the 48 hours prior to the start. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Remarks on exposure duration:
- Due to the change from GMT to BST, the 72 and 96 hour observations were made at 71 and 95 hours. This did not affect the study integrity as no mortality was observed.
- Post exposure observation period:
- None
- Hardness:
- Approximately 144 mg/L as CaCO3
- Test temperature:
- Maintained at approximately 14°C throughout the test.
- pH:
- 7.6 to 7.7 in test vessels
- Dissolved oxygen:
- 8.9 to 10.4 mg O2/L in test vessels.
- Salinity:
- Not applicable
- Conductivity:
- 372 µS/cm
- Nominal and measured concentrations:
- Nominal loading rates: 0 and 100 mg/L
Measured concentrations: Varied based on both Bismuth and Aluminium ion calculations - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass aquaria
- Type (delete if not applicable): open but covered to avoid evaporation
- Material, size, headspace, fill volume: 25 to 30 litre containing 20 litres of test media
- Aeration: Aerated via narrow bore glass tubes
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): NA
- Biomass loading rate: 0.24 g bodyweight/litre
TEST MEDIUM / WATER PARAMETERS
Laboratory tap water was dechlorinated by passage through an activated carbon filter and partly softened giving water with a total hardness of approximately 140 mg/L as CaCO3. After dechlorination and softening the water was passed through a series of computer controlled plate heat exchangers to achieve the required temperature.
At the start of the definitive test the diluent water had a particulate matter concentration of 0.4 mg/L, total water hardness of 144 mg/L as CaCO3, alkalinity of 95.6 mg/L as CaCO3, Total Organic Carbon content of 1.34 mg C/L, chemical oxygen demand of 2.7 mg O2/L and conductivity of 372 μS/cm. The chlorine content ranged from 0.00 to 0.024 mg/L Cl2.
OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 16 hours light and 8 hours darkness
- Light intensity: Not specified
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality and sub-lethal effects (1, 3, 6, 24, 48, 72 and 96 hours after the start of exposure).
TEST CONCENTRATIONS
- Spacing factor for test concentrations: NA as a limit test
- Justification for using less concentrations than requested by guideline: NA as a limit test
- Range finding study: Yes
- Test concentrations: 0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: No effects in the range-finding study (i.e. no mortality at 10 and 100 mg/L). - Reference substance (positive control):
- not required
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: No mortality observed at the limit concentration
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: No mortality observed at the limit concentration
- Details on results:
- - Behavioural abnormalities:
- Observations on body length and weight: None noted
- Other biological observations: None noted
- Mortality of control: None observed
- Other adverse effects control: None observed
- Abnormal responses: None noted
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No microdispersions of test substance noted during preparation and test media appeared clear and colourless although this cannot be conclusively ruled out (i.e. undissolved meterial may have remained). During the test the 100 mg/L loading rate was observed to be slightly hazy/cloudy dispersions.
- Effect concentrations exceeding solubility of substance in test medium: Given that the toxicity cannot be attributed to a single component or a mixture of components (e.g. dissociated ions) but to the test item as a whole, the results were based on nominal loading rates only. - Results with reference substance (positive control):
- Not applicable
- Reported statistics and error estimates:
- Given that the test was conducted as a limit test, statistical analysis of the data was considered not to be necessary, however, LL50 values were determined by inspection of the mortality data at each observation time point.
- Sublethal observations / clinical signs:
Analytical results:
Time point (hours)
Nominal concentration (mg/L)
Sample preparation factor
Determined concentration of Aluminium
Determined concentration of Bismuth
Determined concentration of test item (based on Bismuth)
0
Control
1.02
<LOQ
<LOQ
<LOQ
100
1.02
0.0180
0.242
0.558
24 (old)
Control
1.02
<LOQ
<LOQ
<LOQ
100
1.02
<LOQ
0.194
0.447
72 (fresh)
Control
1.02
0.0169
<LOQ
<LOQ
100
1.02
0.0663
0.499
1.15
96 (old)
Control
1.02
0.0361
<LOQ
<LOQ
100
1.02
0.0438
0.310
0.715
- Validity criteria fulfilled:
- yes
- Remarks:
- The test was considered to be valid given that none of the control fish died or showed signs of stress during the test and that the oxygen concentration at the end of the test was ≥60% of ASV (6.1 mg O2/L) in the control and test vessels.
- Conclusions:
- The acute toxicity of the test item to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and gave a 96-Hour LL50 value of greater than 100 mg/L loading rate WAF. The NOEL rate was 100 mg/L loading rate WAF.
Reference
Description of key information
A reliable OECD guideline study assessing the acute toxicity of the substance to rainbow trout is available. This provides a 96 hour LL50 value of > 100 mg/L. As such no value is included as key for chemical safety assessment as the effect level was determined to be greater than the limit test concentration for tests of this type.
Key value for chemical safety assessment
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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