Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 259-130-3 | CAS number: 54380-33-5
- 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 aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2018-08-06 to 2018-09-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
- Version / remarks:
- 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Remarks:
- HPLC method with UV detection
- Details on sampling:
- - Concentrations: 100 mg/L (limit test)
- Sampling method: For determination of the test item concentrations, four replicate samples (5 mL per replicate) were taken from the test solution (100 mg/L) and from the control at the start and at the end of the test.
- Sample storage conditions before analysis: room temperature - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test solution used in the test was prepared by mechanical dispersion without using of any solubilising agent. An amount of 0.03 g test item was dissolved in 300 mL dilution water (ISO Medium) to obtain the nominal concentration of 100 mg/L. This solution was ultrasonicated for approx. 10 min and then shaken overnight (~300 rpm). To separate possible undissolved material the test solution was filtrated through a 0.45 μm membrane filter before introducing test animals.
- Controls: Untreated control ran parallel in the test.
- Evidence of undissolved material: No - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna (Straus)
- Source: Laboratory of Hydrobiology (Central Agricultural Office, Directorate of Plant-, and Soil Protection) 2100 Gödöllő, Kotlán S. u. 3. Hungary
- Breeding conditions: Daphnia were bred in the laboratory. under similar temperature and light conditions as in the test, and in reconstituted water of a similar quality regarding to pH, components of the main ions and total hardness as the test water used in the test. The test animals were fed with centrifuged green alga suspension.
- Age of parental stock: less than 24 hours old
- Feeding during test: none
ACCLIMATION
- Acclimation period: Test animals were bred under similar conditions as that used during the exposure period, therefore additional acclimatisation before the test was not necessary.
- Health during acclimation: No mortality observed - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- None
- Post exposure observation period:
- no
- Hardness:
- 249 mg/L (as CaCO3)
- Test temperature:
- 19.8 - 20.2 °C
- pH:
- 7.89 - 8.31
- Dissolved oxygen:
- 8.29 - 8.72 mg/L
- Salinity:
- NA
- Conductivity:
- NA
- Nominal and measured concentrations:
- Nominal concentration: 100 mg/L (limit concentration)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: beakers
- Material, size, headspace, fill volume: glass, approximately 40 mL test medium
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Volume/Organism: 2 mL
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The ISO medium was prepared by adding 25 mL from each of four stock solutions to one litre deionised water proportionally.
Stock solution 1: CaCl2 x 2 H2O 11.76 g/L
Stock solution 2: MgSO4 x 7H2O 4.93 g/L
Stock solution 3: NaHCO3 2.59 g/L
Stock solution 4: KCl 0.23 g/L
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light (artificial illumination) and 8 hours darkness
EFFECT PARAMETERS MEASURED:
The immobility or mortality of the Daphnia was determined by visual observation after 24 and 48 hours of exposure. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker were considered to be immobile.
RANGE-FINDING STUDY
- Results used to determine the conditions for the definitive study: A preliminary test was performed at the nominal concentation of 100 mg/L in order to check the toxicity of the test item on the daphnids up to at least this concentration. In the preliminary test no immobility or any sub-lethal effect was detected in the treated concentration and in the control group during the 48-h exposure period. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate (K2Cr2O7)
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: Not observed
- Observations on body length and weight: No effect observed
- Other biological observations: No effect observed
- Mortality of control: No effect observed
- Other adverse effects control: No effect observed
- Immobilisation of control: No effect observed
- Abnormal responses: No effect observed
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No effect observed
- Effect concentrations exceeding solubility of substance in test medium: No
- The 48-h NOEC was determined to be 100 mg/L and 48-h EC50 value was determined to be > 100 mg/L. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- ECx: The 24 h EC50 of the reference substance was determined to be 1.41 mg/L - Reported statistics and error estimates:
- A limit test was performed and toxic effects were not observed. Therefore, statistical analysis was not necessary to evaluate the obtained results.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In a key 48-hour static acute toxicity test with Daphnia magna the test item had no toxic effect on Daphnia at 100 mg/L concentration (i.e. limit test concentration). Accordingly, the 48-h EC50 value was determined to be > 100 mg/L.
- Executive summary:
The acute Toxicity of the test substance to Daphnia magna was determined in a 48-hour Immobilisation Test (Limit test) according to OECD 202 (2004) under GLP conditions. The purpose of this study was to evaluate the influence of the test item on the mobility respectively survival of Daphnia magna. A limit test was performed in which young Daphnia were exposed to aqueous test media containing the test item for 48 hours at the limit test concentration (i.e. 100 mg/L) plus a control in order to demonstrate that the test item is not toxic to Daphnia magna up to at least the concentration of 100 mg/L. The test item and the control were tested using 20 Daphnia, divided into four groups (glass beaker; test medium approx. 40 mL) of five animals each were exposed to the test item concentration or run as control for 48 hours under static conditions.
The immobility or mortality of the Daphnia was determined by visual observation after 24 and 48 hours of exposure. Concentrations of the test item were determined at the start (0 hours) and the end of exposure (48 hours) using a HPLC-UV method. All validity criteria were met and therefore the study is considered as valid. The measured concentrations of the test item were 88 % of the nominal at the start and 84 % at the end of the test. There was no immobilisation observed in twenty daphnids exposed to each test item treated and control group. Further no abnormal behaviour or appearance of test animals was noted. As the analytically measured concentrations remained within ± 20 % of the nominal concentration, the biological results are based on the nominal test item concentration. In conclusion, the 48-h EC50 value was determined to be > 100 mg/L. The 48-h NOEC was determined to be 100 mg/L. All validity criteria were met.
Reference
Description of key information
The short-term toxicity 48-h EC50 value for Daphnia was determined to be > 100 mg/L.
Key value for chemical safety assessment
Additional information
In a key 48-hour static acute toxicity test with Daphnia magna according to OECD 202 (2004) the test item had no toxic effect on Daphnia at 100 mg/L concentration (i.e. limit test concentration). Accordingly, the 48-h EC50 value was determined to be > 100 mg/L. All validity criteria were met. The results are based on nominal test item concentration.
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.