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EC number: 265-449-9 | CAS number: 65113-55-5
- 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 2012-08-21 to 2012-31-10
- 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)
- Deviations:
- yes
- Remarks:
- (since the test item is poorly water soluble, the standard method for the preparation of aqueous media was modified. The test was performed with a saturated solution of the test item)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 72-2 (Aquatic Invertebrate Acute Toxicity Test)
- Deviations:
- yes
- Remarks:
- (since the test item is poorly water soluble, the standard method for the preparation of aqueous media was modified. The test was performed with a saturated solution of the test item)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- PHYSICO-CHEMICAL PROPERTIES
- Water solubility (under test conditions): negligible - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0, 1, 3.2, 10, 32 and 100 % v/v (nominales)
- Sampling method: at 0 and 48 hours for quantitative analysis and pooled.
- Sample storage conditions before analysis: approximately -20°C prior to analysis - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method of preparation: Saturation of the experimental solution:
550 mg of test item was dispersed in 11 liters of reconstituted water (Elendt M7 medium)
Stirring with a propeller at approximately 1500 rpm for 24 hours. After 24 hours the stirring was stopped
Filtration through a 0.2 μm Gelman Acrocap filter (first approximate 500 mL discarded in order to pre-condition the filter) to remove undissolved test item
Obtention of a 100% v/v saturated solution.
Series of dilution to give further test concentration of 32, 10, 3.2 and 0.01 %v/v saturated solution.
Concentrations of the 2 ions of the test item were verified by the chemical analysis at 0 and 48 hrs.
- Application: daphnies were placed in glass jars containing 200 mL of the saturated solution test
- Controls: control group maintained under identical conditions but not exposed to the test item
- Vehicle: none
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Source: in-house laboratory cultures
- Age at study initiation: less than 24 hours old
- Method of breeding:
Adult Daphnia were maintained in 150 mL glass beakers containing Elendt M7 medium in a temperature controlled room at approximately 20 °C. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods. Each culture was fed daily with a mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension. Culture conditions ensured that reproduction was by parthenogenesis. Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours old. The diet and diluent water are considered not to contain any contaminant that would affect the integrity or outcome ofthe study.
- Feeding during test: no
ACCLIMATION
- Acclimation period: no (in house laboratory cultures)
QUARANTINE (wild caught)
- Duration:no quarantine - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- 250 mg/L as CaCO3
- Test temperature:
- 20°C to 21°C
- pH:
- See table 1: pH and dissolved oxygen measurements
- Dissolved oxygen:
- See table 1: pH and dissolved oxygen measurements
- Nominal and measured concentrations:
- Nominal test concentration, in % v/v saturated solution :
a - control
b- 1.0 % v/v
c- 3.2 % v/v
d- 10 % v/v
e- 32 % v/v
f- 100 % v/v
Corresponding Measured test concentrations (Geometric mean between 0-hour and 48-hour measured test concentration) :
a - control
b- 0.0051 mg/L
c- 0.019 mg/L
d- 0.058 mg/L
e- 0.16 mg/L
f- 0.66 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: jar
- Type : closed
- Material, size, headspace, fill volume: 250 mL glass jars
- Aeration: no
- Renewal rate of test solution: no renewal
- No. of organisms per vessel: 5 organisms
- No. of vessels per concentration (replicates): 4 replicates
- No. of vessels per control (replicates): 4 replicates
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water Elend M7 medium (see table 2 for composition).
OTHER TEST CONDITIONS
- Adjustment of pH: yes, for dilution water
- Photoperiod: 16 hours light, 8 hour darkness with 20 minutes dawn and dusk transition period
- Light intensity: 479 to 513 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
TEST CONCENTRATIONS
- Spacing factor for test concentrations: ~3
- Range finding study: yes
- Test concentrations: 0.1, 1 and 100 % v/v saturated solution
- Results used to determine the conditions for the definitive study: cumulative immobilization data from the range-finding study - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate (K2Cr207)
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- ca. 0.011 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: (0.0094 - 0.013 mg/l)
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- ca. 0.005 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- ca. 0.019 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- Observation on test item solubility:
The control, 1.0 and 3.2% v/v saturated solution test preparations were observed to be clear colorless solutions for the duration of the test whilst the 10, 32 and 100 % v/v saturated solution test preparations were observed to be very slightly purple solutions, slightly purple solutions and purple solutions respectively for the duration ofthe test. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- EC50 - 24 hr = 0.75 mg/l (IC 95% 0.56 - 1 mg/l)
- EC50 - 48 hr = 0.45 mg/l (IC 95% 0.42 - 0.48 mg/l) - Reported statistics and error estimates:
- It was not possible to calculate the slope and error of response curve at 24 and 48 hr.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the experimental conditions:
* 48h - EC50 = 0.011 mg/L
* 48h - NOEC = 0.0051 mg/L
* 48h - LOEC = 0.019 mg/L
(geometric mean of measured test concentration) - Executive summary:
Introduction
A study was performed to assess the acute toxicity of the test item to Daphnia magna.The method followed was designed to be compatible with OECD Guidelines. for Testing of Chemicals (April 2004) No 202,"Daphnia sp., Acute Immobilisation Test" referenced as Method C.2 of Commission Regulation (EC) No. 440/2008.
Methods
Information provided by the Sponsor indicated the water solubility of the test item to be negligible. Pre-study solubility work conducted indicated that it was not possible to obtain a testable solution of the test item using traditional methods of preparation e.g. ultrasonication and high shear mixing.
The test item is a precipitated reaction product of constituent 1 (cons. 1) and constituent 2 (cons. 2). Assuming that the test item was a 1:1 stoichiometric mixture of the two components, based on the percentage content of each component, equivalent test item concentrations could be determined.
A pre-study media preparation trial indicated that the use of a saturated solution method of preparation followed by the removal of any undissolved test item by filtration through a 0.2 µm Gelman Acrocap filter (first approximate 500 mL discarded in order to pre-condition the filter) was appropriate for this test item.
Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 animals) were exposed to an aqueous solution of the test item at concentrations of 1.0, 3.2, 10, 32 and 100% v/v saturated solution for 48 hours at a temperature of 20°C to 21°C under static test conditions.
The test item solutions were prepared by stirring an excess (50 mg/L) of test item in test medium using a propeller stirrer at approximately 1500 rpm for 24 hours. After the stirring period any undissolved test item was removed by filtration (0.2 µm Gelman Acrocap filter, first approximate 500 mL discarded in order to pre-condition the filter) to produce a 100% v/v saturated solution of the test item. This saturated solution was then further diluted as necessary, to provide the remaining test groups. The number of immobilized Daphnia were recorded after 24 and 48 hours.
Results
Analysis of the test preparations at 0 hours showed measured cons. 1 concentrations to range from 0.0054 to 0.49 mg/L (equivalent to test item concentrations of 0.011 to 1.0 mg/L). At 48 hours measured cons. 1 concentrations in the range of 0.0054 to 0.38 mg/L (equivalent to test item concentrations of 0.011 to 0.80 mg/L) were obtained.
Analysis of the test preparations at 0 hours showed measured cons. 2 concentrations to range from 0.0027 to 0.40 mg/L (equivalent to test item concentrations of 0.0051 to 0.77 mg/L). A slight decline in measured cons. 2 concentrations was observed at 48 hours in the range of 0.0027 to 0.29 mg/L (equivalent to test item concentrations of 0.0051 to 0.56 mg/L).
Given that variability in results obtained for both components, it was considered appropriate to base the results on the equivalent test item concentrations from analysis of cons. 2 only in order to give a worst case analysis of the data.
Exposure of Daphnia magna to the test item gave the following results based on the geometric mean measured test concentrations:
- EC50 – 48 hr = 0.011 mg/L (IC95%0.0094 – 0.013 mg/L)
- NOEC = 0.0051 mg/l
- LOEC = 0.019 mg/l
Reference
Description of key information
LC50(48h) for freshwater invertebrates (Daphnia magna): 0.011 mg/L (OECD TG 202; static).
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.011 mg/L
Additional information
The EC50 (48 hours) was 0.011 mg/L (measured concentrations) with 95% confidence limits of 0.0094 -0.013 mg/L.
The NOEC was 0.0051 mg/L
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