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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 835-273-2 | CAS number: 852056-62-3
- 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:
- Sep 21, 2018 - Nov 02, 2018
- 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:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- Council Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and the council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test medium (reconstituted water and test item) was prepared freshly. Therefore, the calibrated flask with test medium was treated in an ultrasonic device for 1 hour. Subsequently, the preparation was stirred with a magnetic stirrer for further 23 hours. Afterwards, the formulation was passed through a membrane filter with a pore size of 0.2 µm. The filtrate was used for the study. - Analytical monitoring:
- no
- Vehicle:
- yes
- Details on test solutions:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test medium (reconstituted water and test item) was prepared freshly. Therefore, the calibrated flask with test medium was treated in an ultrasonic device for 1 hour. Subsequently, the preparation was stirred with a magnetic stirrer for further 23 hours. Afterwards, the formulation was passed through a membrane filter with a pore size of 0.2 µm. The filtrate was used for the study.
VEHICLE:
For the reconstituted water the following chemicals (analytical grade) were dissolved in fully demineralized water:
Macro nutrients mg/L
CaCl2 x 2H2O 294.00
MgSO4 x 7H2O 123.25
NaHCO3 64.75
KCl 5.75
Before the start of the experimental part the reconstituted water for fish was prepared. After preparation the water was aerated for 24 hours before using it.
The proportion of Ca to Mg ions was 4:1 and that of Na to K ions 10:1. Hardness: about 228 mg/L CaCO3. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish
- Strain: Dania rerio
- Origin: Max-Planck-Institut, Tübingen, Germany
- Breeder: Institute of Toxicology, Merck KGaA
- Length at study initiation: 2.7 - 2.9 cm
- Weight at study initiation: 0.2 - 0.4 g
- Feeding during test: commercial fish diet during acclimatization
ACCLIMATION
- Acclimation period: The fish were acclimatized to the conditions of the laboratory for more than 14 days and were held in reconstituted water for at least 12 days before testing.
- Acclimation conditions (same as test or not): same
- Health during acclimation (any mortality observed): no - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- no
- Hardness:
- 228 mg/L CaCO3
- Test temperature:
- 20.5 to 21.5°C
- pH:
- 7.49 to 8.00
- Dissolved oxygen:
- 72.8 - 93.1%
- Conductivity:
- 710 µS/cm
- Nominal and measured concentrations:
- Nominal Concentration: 100 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 10L Glass Aquariums
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: Full glas folled with 10L test medium
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): static
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted watr according OECD 203
- Total organic carbon: no data
- Particulate matter: no data
- Metals: no data
- Pesticides:no data
- Chlorine: no data
- Alkalinity: no data
- Ca/mg ratio: 4/1
- Culture medium different from test medium: no
- Intervals of water quality measurement: daily
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12hrs light / 12hrs dark
- Light intensity: no data
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality, clinical symptoms
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: mo mortality observed at 100 mg/L - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: > 0.0000001448 mg/L (limit of water solubility)
- Details on results:
- The 96 hour LC50 for the test material to Zebrafish could not be quantified due to the absence of toxicity at the highest test concentration achievable in water. An aqueous filtrate of 0.1 g/L nominally revealed no aquatic toxicity in the test system.
The 96h LC50 exceeded the water solubility of 0.0000001448 mg/L (nominal >100 mg/L) and, thus, could not be determined in this study.
- Behavioural abnormalities: no
- Observations on body length and weight: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: yes - Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of the present study, an aqueous solution of 100 mg/L of the test item revealed no aquatic toxicity in the test system.The 96h LC50 is greater than the maximum achievable concentration of 0.0000001448 mg/L (nominal > 100 mg/L) and, thus, could not be determined in this study.
- Executive summary:
The objective of this study was to determine the acute toxicity of the test material in the zebrafish (Daniorerio).
For this purpose, 10 fish (test item group) were exposed to a nominal test item concentration of 100 mg/L (limit test) over 96 hours, under defined conditions in an open static system. Additionally, one control group (10 fish) was used.The fish were observed for signs of toxicity or mortality for 96 hours.
The test item concentration in the reconstituted water was not quantified at the start and the end of this study due to the low water solubility (0.0000001448 mg/L calculated). Because of the low water solubility, the compound cannot be detected with standard analytical methods. The development of an analytical method with a sufficiently low detection and quantification limit is complex. Due to the absence of any adverse effects at the saturation concentration, the study was performed without analytical concentration verification.After exposure of zebrafish (Danio rerio) to a nominal concentration of 100 mg/L of the test item for 96 hours no signs of toxicity and no mortality were observed.
For the test material, the following LC50values for zebrafish were determined.
24 h LC50 > 0.0000001448 mg/L (nominal > 100 mg/L)
48 h LC50 > 0.0000001448 mg/L (nominal > 100 mg/L)
72 h LC50 > 0.0000001448 mg/L (nominal > 100 mg/L)
96 h LC50 > 0.0000001448 mg/L (nominal > 100 mg/L)
Under the conditions of the present study, an aqueous solution of 100 mg/L of the test item revealed no aquatic toxicity in the test system.The 96h LC50 is greater than the maximum achievable concentration of 0.0000001448 mg/L (nominal > 100 mg/L) and, thus, could not be determined in this study.
Reference
Description of key information
OECD 203: LC50 (96 h) > 0.0000001448 mg/L (limit of water solubility), 96 -h LC50 > 100 mg/L (nominal)
Key value for chemical safety assessment
Additional information
No adverse effects on fish were observed up to the limit of water solubility (0.0000001448 mg/L). Therefore, the 96 -h LC50 is greater than 100 mg/L (nominal 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.