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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 946-252-3 | 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 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 2018-01-23 to 2018-01-25
- 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:
- 2004
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Batch No.: FK650468
Purity: 100% - Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- - Formulation: A saturated test item solution (nominal loading rate of 100 mg/L) was prepared by dispersing/dissolving the amount of test item into the test medium (ISO Medium) two days before the start of the study. This solution was 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 was removed by filtration through a fine (0.22 μm) filter to give the 100 % saturated solution
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- - Source: István Szent University
- Breeding: The Daphnia are bred in lab. The health of the stock animals is continuously monitored by visual daily checking. Abnormal behaviour or significant decrease of population is recorded.
- Justification of strain: Daphnia magna is the standard species of the acute immobilisation test.
- Number of animals: There were 20 animals in test group and control group respectively, divided into 4 replicates (5 animals / replicate)
- Age of the animals: They were less than 24 h old at the beginning of the test
- Acclimatization: There was no acclimatization because the water used was similar to the culture water. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- 247 mg/L (as CaCO3).
- Test temperature:
- 19.9 – 20.8°C
- pH:
- 7.03 – 7.55
- Dissolved oxygen:
- 7.6 – 8.9 mg/L
- Nominal and measured concentrations:
- -Nominal: 100% saturated solution
- Details on test conditions:
- TEST SYSTEM
- Test vessel: glass beaker with a volume of 50 mL
- Material, size, headspace, fill volume: ~40 mL test solution/flask; 8 mL test solution/animal
- Renewal rate of test solution (frequency/flow rate): 24 h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water (ISO medium, according to OECD 202)
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hour light and 8-hour dark cycle
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
The immobility or mortality of the Daphnia was determined by visual observation 24 and 48 hours after the start of the test. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker are considered to be immobile.
The number of immobilised animals and the percentage of immobility were determined at 24 and 48 hours.
The water temperature was measured daily, the oxygen concentrations and pH of the control and the test solution were measured at the beginning and at the end of the experiment.
VEHICLE CONTROL PERFORMED: no
RANGE-FINDING STUDY
- Test concentrations: 0.1%, 1%, 10%, 100% saturated solution
- Results used to determine the conditions for the definitive study: no toxic response was observed - Reference substance (positive control):
- yes
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 other: % saturated solution
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 other: % saturated solution
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Immobilisation: No immobilised animals were observed at the 24th and 48th hour. No abnormal behaviour or appearance of test animals was detected.
- Results with reference substance (positive control):
- - Results with reference substance valid?
Yes
- The 24h EC50 of Potassium dichromate: 0.65 mg/L, (95 % confidence limits: 0.61 – 0.70 mg/L) - Validity criteria fulfilled:
- yes
- Conclusions:
- The test item had no toxic effect at saturation; the EC50 results and the LOEC are higher than the solubility level of the test item in the test medium.
- Executive summary:
Acute toxicity of test item on Daphnia magna was assessed in an Acute immobilisation test, over an exposure period of 48 hours in a semi-static test system based on OECD 202.
Because no toxic response was observed during the preliminary range-finding test, a Limit Test was carried out using only one test concentration at the solubility level of the test item in the test medium (100 % saturated solution) and one control group in the definitive test.
The biological results are based on the nominal test concentration.
Twenty animals, divided into four groups (glass beaker) of five animals each were used at the test concentration and for the control.
All validity criteria were met during this study.
Under the conditions of this Daphnia magna acute immobilisation study the observed endpoints for the effect of test item were the followings:
The 24h and 48h EC50 value: > 100% saturated solution (nominal)
The 48h EC100 value: > 100% saturated solution (nominal)
The 48h No-Observed Effect Concentration (NOEC): 100% saturated solution (nominal)
The 48h Lowest Observed Effect Concentration (LOEC): > 100% saturated solution (nominal)
Based on the results of this study, the test item had no toxic effect at saturation; the EC50 results and the LOEC are higher than the solubility level of the test item in the test medium.
Reference
Description of key information
The test item had no toxic effect at saturation; the EC50 results and the LOEC are higher than the solubility level of the test item in the test medium.
Key value for chemical safety assessment
Additional information
Acute toxicity of test item on Daphnia magna was assessed in an Acute immobilisation test, over an exposure period of 48 hours in a semi-static test system based on OECD 202.
Because no toxic response was observed during the preliminary range-finding test, a Limit Test was carried out using only one test concentration at the solubility level of the test item in the test medium (100 % saturated solution) and one control group in the definitive test.
The biological results are based on the nominal test concentration.
Twenty animals, divided into four groups (glass beaker) of five animals each were used at the test concentration and for the control.
All validity criteria were met during this study.
Under the conditions of this Daphnia magna acute immobilisation study the observed endpoints for the effect of test item were the followings:
The 24h and 48h EC50 value: > 100% saturated solution (nominal)
The 48h EC100 value: > 100% saturated solution (nominal)
The 48h No-Observed Effect Concentration (NOEC): 100% saturated solution (nominal)
The 48h Lowest Observed Effect Concentration (LOEC): > 100% saturated solution (nominal)
Based on the results of this study, the test item had no toxic effect at saturation; the EC50 results and the LOEC are higher than the solubility level of the test item in the test medium.
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.