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Diss Factsheets
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EC number: 240-566-8 | CAS number: 16499-88-0
- 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:
- 2018-01-08 to 2018-02-23
- 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
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: PFW160573
- Expiration date of the lot/batch: 2018-09-26
- Purity: 99.39%
- Physical state/Appearance: clear colourless liquid
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: no data - Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method:
* Definitive Test: Samples were taken for analysis and stored frozen at 0 and 72 hour (fresh media) and 24 and 72 hour (old media). Duplicate samples, and samples at 24 hour (fresh media), 48 hour (fresh and old media) and 72 hour (old media) were taken and stored frozen should any further analysis be required.
- Sample storage conditions before analysis: All samples were stored frozen prior to analysis - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
A nominal amount of test item (280 mg) was dissolved in test water and the volume adjusted to 1 liter to give the 280 mg/L stock solution from which a dilution was made to give the test concentration of 14 mg/L. The pH of the 280 mg/L stock solution was adjusted in the range of 7.4 to 7.7 prior to use.
The stock solution was inverted several times to ensure adequate mixing and homogeneity.
- Controls: yes
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): All solutions were clear and colourless. - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: Rainbow trout
- Source: Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK
- Length at study initiation (length definition, mean, range and SD): mean: 4.7 cm (standard deviation = 0.3)
- Weight at study initiation (mean and range, SD): mean: 0.85 g (standard deviation = 0.11)
- Feeding during test: no
ACCLIMATION
- Acclimation period: at least 7 days after delivery
- Acclimation conditions (same as test or not): yes
- Type and amount of food: pelleted fish food
- Feeding frequency: daily
- Health during acclimation (any mortality observed): mortality less than 5% seven days before test - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- approximately 140 mg/L as CaCO3
- Test temperature:
- 14 °C
- pH:
- 7.2-8.0
- Dissolved oxygen:
- 9.4-11.5
- Salinity:
- not relevant
- Conductivity:
- not indicated
- Nominal and measured concentrations:
- Final test:
Nominal concentrations: 14 mg/L
Measured concentrations (mg/L) at t=0h (fresh):Measured concentrations (mg/L) at t=24h (old): 0.000915, 13.5
Measured concentrations (mg/L) at t=72h (fresh): 0.000997, 14
Measured concentrations (mg/L) at t=96h (old): 0.00123, 13.9
Nominal and measured concentrations Analysis of the test preparations at 0, 24, 72 and 96 hours showed measured test concentrations to be near nominal and so it was considered justifiable to estimate the LC50 values in terms of the nominal test concentration only - Details on test conditions:
- TEST SYSTEM
- Test vessel: exposure vessels
- Material, size, headspace, fill volume: 25-30 L, all-glass filled with 20L test solution
- Aeration: not during the test
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): not reported
- No. of vessels per control (replicates): not reported
- Biomass loading rate: 0.30 g fish/L
OTHER TEST CONDITIONS
- Photoperiod: 16h light daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Fish were considered to be dead when no reaction was observed after touching the caudal peduncle and visible breathing movements were absent.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: none (limit test)
- Range finding study: no
- Test concentrations:
- Results used to determine the conditions for the definitive study: - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 14 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: none
- 96-h NOEC = 14 mg/L - Reported statistics and error estimates:
- An estimate of the LC50 values was given by inspection of the mortality data.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of the test substance to Rainbow trout was determined in a 96 hour static limit test according to the OECD guideline 203. Analysis of the test preparations at 0, 24, 72 and 96 hours showed measured test concentrations to be near nominal and so the results are based on nominal test concentrations only. Under the conditions of the present study, the 96-h LC50 exceeded the nominal concentration of 14 mg/L. The results of the test can be considered reliable without restriction.
Reference
Description of key information
In accordance with the recommendations of REACH, the test was conducted according to the threshold approach recommended by ECHA. Using this approach the lowest EC50 value from either the Algal Growth Inhibition study or Acute Toxicity to Daphnia magna study is set as the threshold concentration and a “Limit test” is conducted at this threshold concentration. If no mortalities are observed this indicates that fish are not the most sensitive species and that the LC50 is greater than the threshold concentration. The EC50 value obtained from the Algal Growth Inhibition study (Envigo study number KT80PH) was the lowest of these two EC50 values and hence the test was conducted at a single concentration of 14 mg/L.
The acute toxicity of the test substance to Rainbow trout was determined in a 96 hour semi-static limit test according to the OECD guideline 203 (Squance, 2018). Under the conditions of the present study, the 96-h LC50 exceeded the nominal concentration of 14 mg/L, so no EC50 could be derived.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.