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Diss Factsheets
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EC number: 941-224-7 | 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:
- 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: control and nominal 600.4 mg /L active substance
- Sampling method: Specimens were stabilized with 50% methanol immediately after sampling.
- Sample storage conditions before analysis: All specimens were stored deep frozen (≤ -18 °C) until analysis. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method
A stock solution was prepared by adding the test item to test medium.
The stock solution was stirred for 10 minutes on a magnetic stirrer.
Stock solution and test vessels were prepared in the following way:
Stock solution and test vessels were prepared in the following way:
- A stock solution was prepared by weighing of
2.41 g test item at 0 hours = test start
into a graduated flask and filling up to 2000 mL using test medium (= stock solution A, corresponding to 1.205 g/L at test start).
The test solution was prepared directly in the test vessels immediately before the transfer of the fish into the test vessels.
2000 mL stock solution A was mixed with 2 L test medium in the pool to reach the final test concentration of 603 mg/L test item.
The control vessels contained test medium (AAP test medium) only. One day before the start of the test, the test medium was prepared and aerated for 2 hours.
- Controls: blank control
- Test concentration separation factor: not relevant since only one treated test group was used
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): none reported - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebra fish
- Source: purchased from fish supplier „Zierfischcenter Scalar“ Paul-Geißler-Straße 14, 04808 Wurzen, Germany,
- Length at study initiation (length definition, mean, range and SD): 1.76 +/- 0.25 cm
- Weight at study initiation (mean and range, SD): 0.097 +/- 0.02 g
- Maintenance of the brood fish: held in the Test Facility under standardised laboratory conditions
ACCLIMATION
- Acclimation period: 11 days
- Acclimation conditions (same as test or not): yes
- Type and amount of food during acclimation: commercial fish food
- Feeding frequency during acclimation: daily (fish food), until 24 hours before test start, no feeding during the test
- Health during acclimation (any mortality observed): Mortality of fish during the acclimatisation period was 0%. - Test type:
- static
- Water media type:
- freshwater
- Remarks:
- AAP medium according to OECD 201
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 100 mg/L CaCO3
- Test temperature:
- 22.7 – 23.4 °C (recorded continuously)
- pH:
- 7.24 to 7.85
- Dissolved oxygen:
- 8.34 to 8.78 mg/L
- Nominal and measured concentrations:
- control and nominal 603 mg/L (600.4mg /L a.s.), recoveries within 80 to 120 % of nominal,
geom. mean measured concentrtaion 653.4 mg/L a.s. - Details on test conditions:
- TEST SYSTEM
- Test vessel: stainless steel container (approx. 6 L volume)
- Material, size, headspace, fill volume: 4 L
- Aeration: yes
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.17 g/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: AAP-medium according to OECD 201
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light: 8 hours dark
- Light intensity: on average 20 µE *m-2*s-1
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, LC0 and LC50
TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable since threshold test
- Justification for using less concentrations than requested by guideline: threshold test
- Test concentrations: nominal 600.4 mg/L a.m., geom. mean measured 653.4 mg/L a.s. - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 600.4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: no mortality and no abnormal effects observed
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 653.4 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: no mortality and no abnormal effects observed
- Details on results:
- - Other abnormalities: none
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none
- Effect concentrations exceeding solubility of substance in test medium: no - Reported statistics and error estimates:
- not relevant since no mortality observed
- Validity criteria fulfilled:
- yes
- Conclusions:
- 96-hour LC50 > 600.4 mg/L
- Executive summary:
In the Klimisch 1 GLP study from Warning (2022) the acute toxicity of the registered substance to zebra fish (Danio rerio) was determined in a 96‑hour static test according to the OECD Guideline for Testing of Chemicals No. 203 (2019). The following nominal concentration of the registered substance was tested: 600.4 mg/L active substance (=active ingredient; threshold approach). Additionally, a control (test water without test item) was tested in parallel. In the analyzed test medium samples from the start and end of the first and last test medium renewal periods the measured test item concentrations ranged between 106 and 111% of the nominal value (geom. mean measured concentration 653.4 mg/L a.s.). Consequently, the test concentration was stable and the reported biological results are related to the nominal test item concentration.
In the control and at the test concentration no mortality and no sublethal effects were observed throughout the 96-hour test period. Thus, the 96‑hour NOEC, LC0 and LC50 of the registered substance to zebra fish were determined to be >= 600.4, >= 600.4 and > 600.4 mg/L active matter, respectively.
The results of this study are considered relevant and reliable for the risk assessment.
Reference
Description of key information
LC50 for freshwater fish (zebra fish): > 600.4 mg /L
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- LC50
- Effect concentration:
- 600.4 mg/L
Additional information
In the Klimisch 1 GLP study from Warning (2022) the acute toxicity of the registered substance to zebra fish (Danio rerio) was determined in a 96‑hour static test according to the OECD Guideline for Testing of Chemicals No. 203 (2019). The following nominal concentration of the registered substance was tested: 600.4 mg/L active substance (=active ingredient; threshold approach). Additionally, a control (test water without test item) was tested in parallel. In the analyzed test medium samples from the start and end of the first and last test medium renewal periods the measured test item concentrations ranged between 106 and 111% of the nominal value (geom. mean measured concentration 653.4 mg/L a.s.). Consequently, the test concentration was stable and the reported biological results are related to the nominal test item concentration.
In the control and at the test concentration no mortality and no sublethal effects were observed throughout the 96-hour test period. Thus, the 96‑hour NOEC, LC0 and LC50 of the registered substance to zebra fish were determined to be >= 600.4, >= 600.4 and > 600.4 mg/L active matter, respectively.
The results of this study are considered relevant and reliable for the risk assessment.
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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