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EC number: 908-084-9 | 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
- Study period:
- 13 February 2017 - 17 February 2017
- 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:
- EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Samples were taken in plastic tubes, acidified with pure nitric acid (9 mL sample + 1 mL HNO3) in agreement with the requirements of the Principal
Investigator. To avoid any problems with microparticles, therefore the samples were membrane filtrated before acidification.
Samples were taken at the start and end of the first and last renewal periods from all concentration levels. - Vehicle:
- no
- Details on test solutions:
- Because the test item is a multi constituent substance and poorly soluble in water, test solutions were prepared using a saturated solution method (water accommodated fraction, WAF) according to the Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, OECD No. 23.
Saturated test item solutions with nominal loading rates of 0.625, 1.25, 2.5, 5.0 and 10.0 mg/L were individually prepared by dispersing/dissolving the amount of test item into the test medium (aquarium water) two days before the start of the treatments. These solutions were shaken for about 24 hours at approximately 30°C and then equilibrated for about 24 hours at approximately 20°C. The non-dissolved test material were removed by filtration through a fine (0.22 μm) filter to give the 0.625, 1.25, 2.5, 5.0 and 10.0 mg/L nominal lading rate WAFs.
The test solutions were prepared just before introduction of the fish (start of treatments). In absence of stability data the test was performed under semi-static conditions. The frequency of the water renewal periods was 24 hours. Prior to treatment of each renewal period, test item solutions were prepared by the method described above. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- name - zebrafish
Justification - Zebrafish (Brachydanio rerio) is one of the convenient species for acute fish toxicity test.
seven fish per test group
length - 2.7 – 3.3 cm (Body length of animals was in the acceptable range (3.0 ± 0.5 cm))
Acclimatisation: more than 12 days
Fish were bred in a well-known fish farm, under disease- and parasite-controlled conditions. Fish were observed during the acclimatisation and test periods, the fish were healthy. Mortality was less than 5 % of the population for seven days before the test.
The fish were not fed during the test - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- -
- Hardness:
- 152 mg/L (as CaCO3).
- Test temperature:
- between 20.8 and 22.0°C.
- pH:
- 7.68 – 8.36.
- Dissolved oxygen:
- In the range of 69 – 99 % of the air saturation value at the temperature used.
- Salinity:
- -
- Conductivity:
- -
- Nominal and measured concentrations:
- Nominal loading rates (WAF) = 0 (control), 0.625, 1.25, 2.5, 5, and 10.0 mg/L.
The measured concentrations for each concentration level at each measurement timepoint was <0.15 mg/L (based on the concentration of copper <0.013 mg Cu/L) - Details on test conditions:
- The test duration was 96 hours. One aquarium was used for test groups and for the control group, respectively. Each aquarium comprised 7 fish and 5 L test solution. The animals were not fed during the test. The loading of the test aquaria was less than 1.0 g fish/L test solution at the start of the experiment.
- Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- EL50
- Effect conc.:
- 7.95 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- ca. 5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (total fraction)
- Basis for effect:
- mortality (fish)
- Details on results:
- No mortality was seen in the control group or in the 0.625, 1.25, 2.5 and 5 mg/L test groups. 1/7 fish was found dead in the highest dose level (nominal 10 mg/L loading rate) at 72 hours, and 6/7 fish in this group were found dead at 96 hours (cumulative mortality).
Behaviour of fish was found as normal in the control group and at the tested concentration levels with the exception of the highest test level of 10.0 mg/L nominal loading rate WAF.
Decreased activity, localization at the bottom of the aquarium, lateral position, fast motility of operculum and immobility was observed at the highest test concentration group of 10.0 mg/L nominal loading rate WAF during the experiment.
The 24h, 48h and 72h LR50 value: > 10.0 mg/L nominal loading rate WAF
The 96h LR50 value: 7.95 mg/L nominal loading rate WAF (95 % conf. limits: 5.62 – 10.44 mg/L nominal loading rate WAF)
The 96h LR100 value: > 10.0 mg/L nominal loading rate WAF
The 96h No-Observed Effect Loading Rate (NOELR): 5.0 mg/L nominal loading rate WAF
The 96h Lowest Observed Effect Loading Rate (LOELR): 10.0 mg/L nominal loading rate WAF - Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of B331 was assessed with acute fish toxicity test on Zebrafish (Brachydanio rerio), over an exposure period of 96 hours in a semi-static system. Under the conditions of this acute fish toxicity study on Zebrafish (Brachydanio rerio) the observed and calculated endpoints for the effect of B331 were the following:
The 24h, 48h and 72h LR50 value: > 10.0 mg/L nominal loading rate WAF
The 96h LR50 value: 7.95 mg/L nominal loading rate WAF (95 % conf. limits: 5.62 – 10.44 mg/L nominal loading rate WAF)
The 96h LR100 value: > 10.0 mg/L nominal loading rate WAF
The 96h No-Observed Effect Loading Rate (NOELR): 5.0 mg/L nominal loading rate WAF
The 96h Lowest Observed Effect Loading Rate (LOELR): 10.0 mg/L nominal loading rate WAF
Reference
Description of key information
Zebrafish (danio rerio), 96 hours EL50 = 7.95 mg/L (nominal loading rate). NOEL = 5 mg/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 7.95 mg/L
Additional information
An acute fish toxicity study was conducted (CiToxLAB Hungary, 2017) to assess the short-term effects of B331 on fish. The study was conducted according to OECD test guideline 203 and EC method C1, and in compliance with GLP. The test media was prepared as a water accomodated fraction (WAF) with nominal loading rates of 0.625, 1.25, 2.5, 5 and 10 mg/L; a concurrent vehicle control group (untreated dilution water) was used. Test media were replaced every 24 hours.
Analysis of the test solutions in all dose levels at each sampling timepoint revealed the test material concentration to be below the limit of quantitation of 0.15 mg/L (measured for copper concent by ICP-AES; LoQ = 0.013 mg Cu/L).
Deaths were observed in the 10 mg/L dose level at 72 hours and 96 hours. All other dose levels were considered normal (no mortality and no behavioural abnormalities).
The 96 -hour EL50 was 7.95 mg/L. The 96 -hour NOEL = 5 mg/L.
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